Page last updated: 2024-09-21

iron

Description

taconite: iron ore which also contains quartz & silicates; has adverse effects similar to asbestos & silicon [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID27284
CHEBI ID29033
MeSH IDM0011718

Synonyms (42)

Synonym
iron ion(2+)
CHEBI:29033
iron(2+) ion
iron(ii) cation
iron(2+)ions
iron ion (2+)
iron, ion(fe 2+)
iron (fe 2+)
iron (ii) ion
fe++
iron divalent ion
ferrous cation
ferrous ions
ferrous
iron dication
iron(2+) ions
fe(ii)
iron(ii)
ferrous ion
FE+2 ,
fe2+
feii
iron(2+)
15438-31-0
fe(2+)
infed
fe +2
unii-gw89581owr
gw89581owr ,
iron, ion (fe2+)
taconite
limonite
iron(ii) ion
iron (ii)
CWYNVVGOOAEACU-UHFFFAOYSA-N
fe +2 ion
DTXSID4042672
wrought iron
malleable iron
DB14510
Q428946
pyrite8137

Roles (4)

RoleDescription
human metaboliteAny mammalian metabolite produced during a metabolic reaction in humans (Homo sapiens).
Saccharomyces cerevisiae metaboliteAny fungal metabolite produced during a metabolic reaction in Baker's yeast (Saccharomyces cerevisiae).
mouse metaboliteAny mammalian metabolite produced during a metabolic reaction in a mouse (Mus musculus).
cofactorAn organic molecule or ion (usually a metal ion) that is required by an enzyme for its activity. It may be attached either loosely (coenzyme) or tightly (prosthetic group).
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (3)

ClassDescription
iron cation
monoatomic dication
divalent metal cationA metal cation with a valence of two.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (491)

iron is involved in 491 pathway(s), involving a total of 21066 unique proteins and 18440 unique compounds

PathwayProteinsCompounds
Transport of small molecules39295
SLC-mediated transmembrane transport13567
Transport of bile salts and organic acids, metal ions and amine compounds4928
Metal ion SLC transporters147
Iron uptake and transport2919
Transferrin endocytosis and recycling107
Developmental Biology72730
Extracellular matrix organization13520
Collagen formation1914
Collagen biosynthesis and modifying enzymes89
Metabolism14961108
Inositol phosphate metabolism3235
Synthesis of IP2, IP, and Ins in the cytosol517
Metabolism of lipids500463
Fatty acid metabolism113203
Arachidonic acid metabolism3682
Synthesis of Leukotrienes (LT) and Eoxins (EX)1329
Synthesis of 5-eicosatetraenoic acids615
Synthesis of 15-eicosatetraenoic acid derivatives314
Synthesis of 12-eicosatetraenoic acid derivatives412
Synthesis of Hepoxilins (HX) and Trioxilins (TrX)14
Peroxisomal lipid metabolism2552
Alpha-oxidation of phytanate625
Sphingolipid metabolism5550
Sphingolipid de novo biosynthesis1716
Metabolism of steroids111135
Bile acid and bile salt metabolism3171
Synthesis of bile acids and bile salts2068
Biosynthesis of specialized proresolving mediators (SPMs)13107
Synthesis of Lipoxins (LX)616
Biosynthesis of DHA-derived SPMs1156
Biosynthesis of DPA-derived SPMs419
Biosynthesis of DPAn-6 SPMs24
Biosynthesis of DPAn-3 SPMs417
Biosynthesis of DPAn-3-derived maresins210
Nucleotide metabolism89125
Nucleotide biosynthesis1246
Purine ribonucleoside monophosphate biosynthesis936
Metabolism of vitamins and cofactors146155
Metabolism of fat-soluble vitamins2623
Retinoid metabolism and transport2217
Metabolism of cofactors1947
Ubiquinol biosynthesis824
Tetrahydrobiopterin (BH4) synthesis, recycling, salvage and regulation1025
Amino acid and derivative metabolism250260
Carnitine synthesis416
Histidine, lysine, phenylalanine, tyrosine, proline and tryptophan catabolism4485
Phenylalanine and tyrosine catabolism1131
Tryptophan catabolism1426
Methionine salvage pathway616
Metabolism of amine-derived hormones1440
Catecholamine biosynthesis418
Serotonin and melatonin biosynthesis315
Sulfur amino acid metabolism2763
Degradation of cysteine and homocysteine1538
Porphyrin metabolism2344
Heme biosynthesis1530
Heme degradation1021
Biological oxidations150276
Phase I - Functionalization of compounds69175
Cytochrome P450 - arranged by substrate type30110
Mitochondrial iron-sulfur cluster biogenesis1111
DNA Repair25547
DNA Damage Reversal810
Reversal of alkylation damage by DNA dioxygenases79
ALKBH2 mediated reversal of alkylation damage17
ALKBH3 mediated reversal of alkylation damage47
Signaling Pathways1269117
Signaling by GPCR24955
GPCR downstream signalling17252
G alpha (i) signalling events8741
Opioid Signalling2319
DARPP-32 events711
Visual phototransduction6241
Cellular responses to stimuli48356
Cellular responses to stress46954
Oxygen-dependent proline hydroxylation of Hypoxia-inducible Factor Alpha556
Cellular Senescence849
Oxidative Stress Induced Senescence257
Cell Cycle53831
Cell Cycle, Mitotic41031
M Phase27921
Mitotic Prophase6214
Condensation of Prophase Chromosomes1310
Events associated with phagocytolytic activity of PMN cells213
Porphyrin Metabolism1636
Acute Intermittent Porphyria1636
Porphyria Variegata (PV)1636
Congenital Erythropoietic Porphyria (CEP) or Gunther Disease1636
Hereditary Coproporphyria (HCP)1636
Biosynthesis of Siderophore Group Nonribosomal Peptides1821
Metabolism of proteins1058144
Post-translational protein modification666112
Gamma carboxylation, hypusinylation, hydroxylation, and arylsulfatase activation4626
Hypusinylation28
Disease1278231
Disorders of transmembrane transporters10243
SLC transporter disorders4537
Defective CP causes aceruloplasminemia (ACERULOP)14
Defective SLC11A2 causes hypochromic microcytic anemia, with iron overload 1 (AHMIO1)02
Defective SLC40A1 causes hemochromatosis 4 (HFE4) (macrophages)12
Diseases of metabolism69121
Phenylketonuria14
Infectious disease89579
Latent infection of Homo sapiens with Mycobacterium tuberculosis3232
Latent infection - Other responses of Mtb to phagocytosis3233
Tolerance of reactive oxygen produced by macrophages118
Mtb iron assimilation by chelation610
Gene expression (Transcription)90249
reactive oxygen species degradation011
superpathway of proto- and siroheme biosynthesis1638
Epigenetic regulation of gene expression11717
Oxidative demethylation of DNA49
Immune System91482
Innate Immune System41475
ROS and RNS production in phagocytes1237
Metabolism of RNA63740
tRNA processing10729
tRNA modification in the nucleus and cytosol4325
Synthesis of wybutosine at G37 of tRNA(Phe)616
stachyose biosynthesis523
superpathway of plastoquinol biosynthesis318
methyl indole-3-acetate interconversion212
quercetin gentiotetraside biosynthesis317
isoflavonoid biosynthesis II124
gossypetin metabolism025
vitamin E biosynthesis (tocopherols)017
heme b biosynthesis I (aerobic)612
(S)-reticuline biosynthesis I030
suberin monomers biosynthesis1036
chrysin biosynthesis112
eupatolitin 3-O-glucoside biosynthesis030
luteolin biosynthesis615
kaempferol gentiobioside biosynthesis317
glucosinolate activation115
polymethylated quercetin glucoside biosynthesis I - quercetin series (Chrysosplenium)226
coniferyl alcohol 9-methyl ester biosynthesis28
hyperforin and adhyperforin biosynthesis013
superpathay of heme b biosynthesis from glutamate1128
gibberellin biosynthesis II (early C-3 hydroxylation)415
Fe(II)-nicotianamine transport in phloem12
coumarins biosynthesis (engineered)628
rosmarinic acid biosynthesis II023
5-deoxystrigol biosynthesis310
superpathway of betalain biosynthesis241
flavonol glucosylation I118
superpathway of rosmarinic acid biosynthesis140
myricetin gentiobioside biosynthesis316
hydroxycinnamic acid tyramine amides biosynthesis021
lupanine biosynthesis017
siroheme biosynthesis111
polymethylated quercetin glucoside biosynthesis II - quercetagetin series (Chrysosplenium)231
iron reduction and absorption125
volatile cinnamoic ester biosynthesis016
berberine biosynthesis032
betalamic acid biosynthesis114
phytate degradation I316
plastoquinol-9 biosynthesis I013
superpathway of polymethylated quercetin/quercetagetin glucoside biosynthesis (Chrysosplenium)234
(-)-4'-demethyl-epipodophyllotoxin biosynthesis111
superpathway of anaerobic sucrose degradation3360
sucrose degradation II (sucrose synthase)1722
Phenylalanine and tyrosine metabolism1132
Phenylalanine metabolism621
Tyrosine catabolism515
Infection with Mycobacterium tuberculosis7442
Neurodegeneration with brain iron accumulation (NBIA) subtypes pathway016
Bloch Pathway (Cholesterol Biosynthesis)929
Kandutsch-Russell Pathway (Cholesterol Biosynthesis)930
phytochromobilin biosynthesis17
morphine biosynthesis234
heme degradation I014
vindoline, vindorosine and vinblastine biosynthesis240
Renz2020 - GEM of Human alveolar macrophage with SARS-CoV-20490
HMOX1 pathway (COVID-19 Disease Map)3630
Electron Transport Chain (COVID-19 Disease Map)1120
3q29 copy number variation syndrome012
Riboflavin and CoQ disorders1627
Cellular response to chemical stress16740
Cytoprotection by HMOX13419
Sensory Perception21568
Antiviral and anti-inflammatory effects of Nrf2 on SARS-CoV-2 pathway16
Alzheimer's disease211
superpathway of heme b biosynthesis from glutamate022
Bacterial Infection Pathways12347
11p11.2 copy number variation syndrome216
Iron metabolism disorders04
Protein hydroxylation205
Maternal to zygotic transition (MZT)6017
Chromatin modifications during the maternal to zygotic transition (MZT)149
NAD de novo biosynthesis1233
heme biosynthesis from uroporphyrinogen-III I413
heme biosynthesis920
tryptophan degradation1345
L-kynurenine degradation1352
superpathway of tryptophan utilization4292
tryptophan degradation to 2-amino-3-carboxymuconate semialdehyde722
fatty acid u03B1-oxidation417
tyrosine degradation517
polymethylated quercetin glucoside biosynthesis I - quercetin series (Chrysosplenium)231
myricetin gentiobioside biosynthesis317
NAD/NADP-NADH/NADPH cytosolic interconversion (yeast)526
vindoline and vinblastine biosynthesis635
superpathway NAD/NADP - NADH/NADPH interconversion (yeast)1031
polymethylated quercetin glucoside biosynthesis II - quercetagetin series (Chrysosplenium)238
ethylene glycol degradation29
(S)-propane-1,2-diol degradation618
superpathway of glycol metabolism and degradation1035
pentachlorophenol degradation425
5-aminoimidazole ribonucleotide biosynthesis I1238
2-nitrobenzoate degradation I723
procollagen hydroxylation and glycosylation914
ammonia assimilation cycle III433
cytidine-5'-diphosphate-glycerol biosynthesis315
ethylene biosynthesis IV (engineered)218
rosmarinic acid biosynthesis II122
N-acetylneuraminate and N-acetylmannosamine degradation I416
thiosulfate disproportionation II (cytochrome)19
heme b biosynthesis II (anaerobic)413
anthranilate degradation I (aerobic)78
heme b biosynthesis IV (Gram-positive bacteria)314
superpathay of heme b biosynthesis from glutamate2047
superpathway of heme b biosynthesis from uroporphyrinogen-III517
superpathway of b heme biosynthesis from glycine1046
heme b biosynthesis I (aerobic)1428
2-keto-L-gulonate biosynthesis417
colanic acid building blocks biosynthesis949
morphine biosynthesis536
berberine biosynthesis132
retinol biosynthesis139
2-aminoethylphosphonate degradation III210
spermidine biosynthesis I635
CMP-N-acetylneuraminate biosynthesis I (eukaryotes)738
poly(3-O-u03B2-D-glucopyranosyl-N-acetylgalactosamine 1-phosphate) wall teichoic acid biosynthesis1233
methyl indole-3-acetate interconversion013
indole-3-acetate biosynthesis IV (bacteria)07
L-tryptophan degradation to 2-amino-3-carboxymuconate semialdehyde1222
scopoletin biosynthesis515
suberin monomers biosynthesis1342
umbelliferone biosynthesis114
esculetin biosynthesis19
coumarins biosynthesis (engineered)831
photosynthetic 3-hydroxybutanoate biosynthesis (engineered)6373
autoinducer AI-2 biosynthesis I319
autoinducer AI-2 biosynthesis II (Vibrio)213
L-glutamine degradation II418
superpathway of the 3-hydroxypropanoate cycle1634
3-hydroxypropanoate cycle1329
superpathway of pyrimidine deoxyribonucleosides degradation738
superpathway of L-phenylalanine biosynthesis1665
stachyose biosynthesis323
isoflavonoid biosynthesis II128
stipitatate biosynthesis424
eugenol and isoeugenol biosynthesis813
volatile cinnamoic ester biosynthesis216
12-epi-hapalindole biosynthesis515
t-anethole biosynthesis215
superpathway of rosmarinic acid biosynthesis243
paerucumarin biosynthesis212
D-galactarate degradation I530
ethanol degradation I415
atrazine degradation I (aerobic)413
ethanolamine utilization1336
superpathway of L-lysine degradation33112
coenzyme M biosynthesis I528
L-lysine degradation IV039
L-lysine degradation III126
superpathway of N-acetylglucosamine, N-acetylmannosamine and N-acetylneuraminate degradation924
violacein biosynthesis520
aromatic biogenic amine degradation (bacteria)335
rhabduscin biosynthesis313
L-tyrosine degradation I1023
L-lysine degradation IX015
hapalindole H biosynthesis614
aflatoxins B1 and G1 biosynthesis218
curcumin degradation117
anditomin biosynthesis1235
superpathway of dimethylsulfone degradation219
5-deoxystrigol biosynthesis311
3-amino-5-hydroxybenzoate biosynthesis324
superpathway of microbial D-galacturonate and D-glucuronate degradation3592
L-glutamate and L-glutamine biosynthesis1442
heme degradation V213
heme degradation VI28
heme degradation III19
2,4-dinitrotoluene degradation720
serotonin and melatonin biosynthesis717
heme degradation VII18
heme degradation II38
catecholamine biosynthesis328
heme degradation I314
2-oxobutanoate degradation I1028
L-asparagine degradation I425
superpathway of purine deoxyribonucleosides degradation637
flavin biosynthesis II (archaea)828
L-carnitine degradation III724
sulfur oxidation II (Fe+3-dependent)016
superpathway of purine nucleotides de novo biosynthesis I3649
dTDP-N-acetylviosamine biosynthesis216
chrysophanol biosynthesis07
4-hydroxyacetophenone degradation520
methylgallate degradation1122
carbazole degradation611
superpathway of nicotinate degradation1254
3-methylquinoline degradation016
5,5'-dehydrodivanillate degradation516
noradrenaline and adrenaline degradation823
S-methyl-5-thio-u03B1-D-ribose 1-phosphate degradation I1320
L-lysine fermentation to acetate and butanoate857
4-amino-3-hydroxybenzoate degradation240
terephthalate degradation410
superpathway of aromatic compound degradation via 2-hydroxypentadienoate5095
mixed acid fermentation3276
stephacidin A biosynthesis217
purine nucleobases degradation I (anaerobic)240
purine nucleobases degradation II (anaerobic)051
phytate degradation I021
superpathway of aromatic compound degradation via 3-oxoadipate3681
2-aminophenol degradation921
3-phenylpropanoate and 3-(3-hydroxyphenyl)propanoate degradation1122
6-hydroxymethyl-dihydropterin diphosphate biosynthesis II (Methanocaldococcus)417
heparin degradation315
chondroitin sulfate degradation I (bacterial)413
benzene degradation411
2,5-xylenol and 3,5-xylenol degradation427
superpathway of demethylmenaquinol-8 biosynthesis I1133
nitrilotriacetate degradation222
syringate degradation1224
2-amino-3-carboxymuconate semialdehyde degradation to glutaryl-CoA226
vitamin E biosynthesis (tocopherols)518
superpathway of N-acetylneuraminate degradation3979
nicotine degradation II (pyrrolidine pathway)1034
nicotine degradation III (VPP pathway)1032
norspermidine biosynthesis725
superpathway of polyamine biosynthesis I759
superpathway of polyamine biosynthesis III728
pyrimidine ribonucleosides salvage III613
phycoerythrobilin biosynthesis II09
ammonia oxidation III016
ammonia oxidation IV (autotrophic ammonia oxidizers)724
superpathway of arginine and polyamine biosynthesis18101
ammonia oxidation I (aerobic)924
meso-butanediol biosynthesis I26
nicotinate degradation III1241
phycoviolobilin biosynthesis49
glycerol degradation III613
nicotinate degradation I833
luteolin biosynthesis316
phycoerythrobilin biosynthesis I310
phycourobilin biosynthesis410
phytochromobilin biosynthesis49
pyrimidine nucleobases salvage II418
phycocyanobilin biosynthesis59
4-amino-2-methyl-5-diphosphomethylpyrimidine biosynthesis (yeast)729
kanamycin biosynthesis1042
superpathway of rifamycin B biosynthesis1354
photosynthesis light reactions1478
novobiocin biosynthesis1741
validamycin biosynthesis1034
fatty acid u03B1-oxidation II718
fosfomycin biosynthesis426
caffeine degradation III (bacteria, via demethylation)521
superpathway of penicillin, cephalosporin and cephamycin biosynthesis1169
starch degradation III115
L-valine biosynthesis1634
deacetylcephalosporin C biosynthesis444
sulfur disproportionation II (aerobic)112
FR-900098 and FR-33289 antibiotics biosynthesis726
neopentalenoketolactone and pentalenate biosynthesis725
streptomycin biosynthesis452
CDP-D-arabitol biosynthesis215
taurine biosynthesis I420
CDP-D-mannitol biosynthesis212
glycogen degradation I850
3-[(E)-2-isocyanoethenyl]-1H-indole biosynthesis212
L-histidine biosynthesis1833
L-methionine salvage cycle I (bacteria and plants)1938
gentisate degradation II311
pectin degradation I311
UDP-N-acetyl-D-glucosamine biosynthesis II2333
phosphinothricin tripeptide biosynthesis1956
D-galactose degradation I (Leloir pathway)1046
lincomycin biosynthesis316
L-threonine degradation IV415
L-arginine biosynthesis I (via L-ornithine)1153
dehydrophos biosynthesis1025
L-threonine degradation II331
L-threonine degradation III (to methylglyoxal)328
lupanine biosynthesis019
meta cleavage pathway of aromatic compounds1422
superpathway of aromatic amino acid biosynthesis2184
protocatechuate degradation I (meta-cleavage pathway)1529
protocatechuate degradation III (para-cleavage pathway)515
D-glucuronate degradation I221
dimethyl sulfide degradation I217
superpathway of u03B2-D-glucuronosides degradation1136
cob(II)yrinate a,c-diamide biosynthesis II (late cobalt incorporation)1444
superpathway of cholesterol degradation II (cholesterol dehydrogenase)3058
hyperforin and adhyperforin biosynthesis018
superpathway of cholesterol degradation I (cholesterol oxidase)1755
3-phenylpropanoate and 3-(3-hydroxyphenyl)propanoate degradation to 2-hydroxypentadienoate815
superpathway of sulfur oxidation (Acidianus ambivalens)322
chorismate biosynthesis I1559
superpathway of acrylonitrile degradation010
mercaptosuccinate degradation19
glyoxylate assimilation1131
CMP-8-amino-3,8-dideoxy-D-manno-octulosonate biosynthesis319
superoxide radicals degradation914
superpathway of CMP-sialic acids biosynthesis1460
sucrose degradation II (sucrose synthase)1320
L-glutamate biosynthesis I212
flaviolin dimer and mompain biosynthesis622
glycolysis V (Pyrococcus)730
L-lactaldehyde degradation (anaerobic)29
catechol degradation to 2-hydroxypentadienoate II412
L-rhamnose degradation II623
catechol degradation to 2-hydroxypentadienoate I28
catechol degradation II (meta-cleavage pathway)819
L-cysteine degradation I214
catechol degradation I (meta-cleavage pathway)817
L-ornithine biosynthesis I634
siroheme biosynthesis811
siroheme amide biosynthesis111
2-carboxy-1,4-naphthoquinol biosynthesis2129
glycogen biosynthesis I (from ADP-D-Glucose)425
androstenedione degradation3439
superpathway of dTDP-glucose-derived O-antigen building blocks biosynthesis2836
superpathway of L-tyrosine biosynthesis1557
superpathway of menaquinol-8 biosynthesis I1036
plastoquinol-9 biosynthesis I014
superpathway of plastoquinol biosynthesis119
L-arginine degradation VIII (arginine oxidase pathway)325
superpathway of chorismate metabolism56186
gallate degradation I1015
gallate degradation III (anaerobic)130
toluene degradation IV (aerobic) (via catechol)1625
UDP-u03B1-D-glucose biosynthesis I1424
superpathway of D-glucarate and D-galactarate degradation637
superpathway of taurine degradation637
superpathway of fucose and rhamnose degradation1141
L-tryptophan degradation III (eukaryotic)1745
reactive oxygen species degradation717
L-ascorbate biosynthesis V127
lipoate biosynthesis and incorporation II211
superpathway of glycerol degradation to 1,3-propanediol826
superpathway of UDP-glucose-derived O-antigen building blocks biosynthesis1139
Fe(II) oxidation911
pentose phosphate pathway929
superpathway of atrazine degradation718
iron reduction and absorption54
aminopropanol phosphate biosynthesis II328
oleate biosynthesis II (animals and fungi)48
pentose phosphate pathway (non-oxidative branch)619
D-galacturonate degradation I527
D-fructuronate degradation829
superpathway of betalain biosynthesis252
betalamic acid biosynthesis214
superpathway of hexuronide and hexuronate degradation838
superpathway of sulfide oxidation (Acidithiobacillus ferrooxidans)226
superpathway of L-tryptophan biosynthesis1665
ginsenosides biosynthesis1032
superpathway of L-threonine metabolism2172
anthocyanin biosynthesis (pelargonidin 3-O-glucoside)213
L-carnitine biosynthesis623
anthocyanin biosynthesis29
superpathway of anaerobic sucrose degradation2661
gibberellin inactivation II (methylation)216
superpathway of aerobic toluene degradation3847
3-chlorocatechol degradation III (meta pathway)111
(S)-reticuline biosynthesis I128
2,4,5-trichlorophenoxyacetate degradation622
2,4-dichlorophenoxyacetate degradation314
coniferyl alcohol 9-methyl ester biosynthesis29
epoxypseudoisoeugenol-2-methylbutanoate biosynthesis222
L-tryptophan degradation XI (mammalian, via kynurenine)1356
glucose and glucose-1-phosphate degradation434
2'-deoxy-u03B1-D-ribose 1-phosphate degradation428
oxygenic photosynthesis7128
glucosinolate activation37
aromatic glucosinolate activation111
trehalose biosynthesis V57
ergothioneine biosynthesis I (bacteria)522
ergothioneine biosynthesis II (fungi)215
superpathway of gibberellin biosynthesis2339
4-toluenesulfonate degradation I614
superpathway of L-methionine salvage and degradation2869
ethylene biosynthesis II (microbes)119
ethylene biosynthesis III (microbes)015
ethylene biosynthesis V (engineered)7842
pyruvate fermentation to ethanol I1020
3-dehydroquinate biosynthesis I531
L-isoleucine biosynthesis II1430
S-adenosyl-L-methionine cycle I417
nitrifier denitrification1425
NAD de novo biosynthesis II (from tryptophan)1835
eupatolitin 3-O-glucoside biosynthesis031
3-dimethylallyl-4-hydroxybenzoate biosynthesis314
superpathway of polymethylated quercetin/quercetagetin glucoside biosynthesis (Chrysosplenium)246
taurine degradation IV116
quercetin gentiotetraside biosynthesis319
galactose degradation I (Leloir pathway)526
salvage pathways of pyrimidine ribonucleotides936
ethylene biosynthesis815
superpathway of thiamin diphosphate biosynthesis III (eukaryotes)2541
superpathway of heme biosynthesis818
superpathway NAD/NADP - NADH/NADPH interconversion1129
NAD/NADP-NADH/NADPH cytosolic interconversion626
4-amino-2-methyl-5-phosphomethylpyrimidine biosynthesis1229
heme biosynthesis I (aerobic)712
superpathway of proto- and siroheme biosynthesis1640
heme biosynthesis from uroporphyrinogen-III II012
heme biosynthesis II (anaerobic)010
superpathway of heme biosynthesis from uroporphyrinogen-III013
superpathay of heme biosynthesis from glutamate721
heme biosynthesis from uroporphyrinogen-III II (anaerobic)511
heme biosynthesis from uroporphyrinogen-III I (aerobic)611
superpathway of heme biosynthesis from glycine418
heme degradation47
Fe(III)-reduction and Fe(II) transport15
heme biosynthesis II918
heme biosynthesis I022
phycoerythrobilin biosynthesis09
superpathway of aromatic compound degradation3349
Folic acid network070
Iron homeostasis01
Folate metabolism156
Alzheimer's disease and miRNA effects211
Dopamine metabolism032
Nanoparticle triggered regulated necrosis26
Methionine de novo and salvage pathway148
Oxidation by cytochrome P45008
Ferroptosis133
Heme biosynthesis012
Response to iron deficiency1017
Iron uptake and transport in root vascular system85
Heme synthesis324

Research

Studies (36)

TimeframeStudies, This Drug (%)All Drugs %
pre-19904 (11.11)18.7374
1990's1 (2.78)18.2507
2000's13 (36.11)29.6817
2010's14 (38.89)24.3611
2020's4 (11.11)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials0 (0.00%)5.53%
Reviews3 (7.69%)6.00%
Case Studies2 (5.13%)4.05%
Observational0 (0.00%)0.25%
Other34 (87.18%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (179)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase III, Randomised, Open-label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®) and Iron Sucrose in Subjects With Iron Deficiency Anemia (FERWON-IDA)[NCT02940886]Phase 31,512 participants (Actual)Interventional2016-11-08Completed
Is Iron Supplementation Harmful in Populations Where Iron Deficiency is Not the Cause of Anemia? A 12 Week Randomized Controlled Trial in Cambodia[NCT04017598]Phase 4480 participants (Actual)Interventional2019-12-10Active, not recruiting
To Compare the Efficacy of I.V 200 mg Iron Sucrose and 500 mg Iron Sucrose to Treat Anemia in Pregnancy[NCT02441439]0 participants (Actual)Interventional2022-01-01Withdrawn(stopped due to The investigators decided not to proceed with this study)
Effects of Intravenous Iron Supplementation on Exercise Capacity During Sustained Alveolar Hypoxia in Healthy Humans.[NCT01265108]Phase 112 participants (Actual)Interventional2010-11-30Completed
Can Prebiotics Support the Treatment of Mild Iron Deficiency by Iron Supplementation[NCT03850652]20 participants (Anticipated)Interventional2019-03-06Recruiting
Efficacy of Iron Fortified Ultra Rice Compared to Supplemental Iron Drops in Infants and Young Children[NCT00839761]175 participants (Actual)Interventional2006-12-31Completed
Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous Infusion to Patients With Non-Dialysis Dependent Chronic Kidney Disease (PK-CKD-03)[NCT01213992]Phase 116 participants (Actual)Interventional2012-03-31Completed
Efficacy and Safety of Erythropoietin And/Or Intravenous Iron Sucrose For Treatment of Anemia In Hip and Knee Arthroplasty: A Single-center Retrospective Study[NCT03917394]780 participants (Anticipated)Observational2019-04-24Recruiting
Trial of Pre-Pregnancy Supplements[NCT01183572]802 participants (Actual)Interventional2010-08-31Completed
Multicenter, Open-label Active-controlled Randomized Study of Efficacy and Safety of Ferrum Lek® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Lek d.d., Slovenia) Compared With Maltofer® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewab[NCT03993288]Phase 3267 participants (Actual)Interventional2019-06-27Completed
Assessment of Iron Absorption and Requirements During Pregnancy and Lactation in Kenyan Women[NCT05973552]250 participants (Anticipated)Observational2023-07-31Recruiting
Verification of Correlation Between Genetic Testing of Nutritional Metabolism and Clinical Biochemical Indicators[NCT03651934]600 participants (Anticipated)Interventional2018-10-01Not yet recruiting
Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions[NCT03944733]0 participants (Actual)Interventional2019-12-01Withdrawn(stopped due to The study was never started as a result of change of personnel and funding)
A Double-blind, Placebo Controlled Study to Assess Efficacy of 5-Aminolevulinic Acid in Subjects With Iron Deficiency Anemia[NCT01380548]135 participants (Anticipated)Interventional2011-06-30Completed
Iron Deficiency Anemia and Infant Behavior: Preventive Trial[NCT01166451]835 participants (Actual)Interventional1991-09-30Completed
Effectiveness of Adaptation of the Dose of Iron Supplementation in Pregnancy on Maternal-child Health. Randomized Clinical Trial (ECLIPSES)[NCT03196882]Phase 4704 participants (Actual)Interventional2013-07-10Completed
Use of Cast Iron Pots to Improve Maternal Anemia[NCT02341300]34 participants (Actual)Interventional2020-07-15Terminated(stopped due to Original investigator has left the institution.)
A Cluster-randomized, Non-inferiority Open-label Trial of the Impact of Supplementation Regimen on Consumption of Prenatal Calcium and Iron/Folic Acid Supplements and Adherence to Related Recommendations[NCT02238704]1,032 participants (Actual)Interventional2014-09-30Completed
A Randomized Trial to Determine if RBCs From Donors With Iron Deficient Erythropoiesis Have Decreased Post-transfusion RBC Recovery and Whether Iron Repletion Improves Recovery[NCT02889133]85 participants (Actual)Interventional2017-01-31Active, not recruiting
A Randomized Controlled Pilot Study of Goal-directed Iron Supplementation of Anemic, Critically Ill Trauma Patients With Functional Iron Deficiency, With and Without Oxandrolone[NCT02047552]Phase 20 participants (Actual)Interventional2015-01-31Withdrawn(stopped due to No Participants enrolled)
A Phase III, Randomised, Open-label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®) and Iron Sucrose in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Dis[NCT02940860]Phase 31,538 participants (Actual)Interventional2016-11-29Completed
Fermented Iron-rich Supplement in Reducing Anemia[NCT02037724]Phase 2120 participants (Anticipated)Interventional2014-03-31Not yet recruiting
Efektifitas Pemberian Zat Besi Dan Vitamin D Terhadap Status Besi Pada Anak Dengan Anemia Defisiensi Besi[NCT06148545]57 participants (Actual)Interventional2023-03-30Completed
A Study of Efficacy and Safety of Three Different Oral Iron-Containing Dietary Supplements in Correction of Hematological Indices and Replenishment of Depleted Iron Stores in Iron Deficient Adults With or Without Mild Microcytic Anemia[NCT05185024]152 participants (Actual)Interventional2022-01-19Active, not recruiting
Intravenous Ferric Carboxymaltose Versus Oral Ferrous Sulfate Replacement in Anaemia Due to Acute Nonvariceal Gastrointestinal Bleeding (FIERCE): Protocol of a Multicentre Randomised Controlled Trial[NCT05060731]Phase 4570 participants (Anticipated)Interventional2024-09-01Not yet recruiting
A Randomized Open-label Trial Cross-over Trial of Iron Isomaltoside 1000 (Monofer®) Compared With Iron Sucrose (Venofer®) in Peritoneal Dialysis Patients[NCT03610230]16 participants (Actual)Interventional2019-02-01Terminated(stopped due to Difficult patient recruitment due to COVID-19 epidemic)
Obesity, Iron Regulation and Colorectal Cancer Risk[NCT03548948]17 participants (Actual)Interventional2015-07-15Completed
A Repeat Dose, Open Label, Two Period, Randomized, Cross Over Study to Compare the Effect of Daprodustat to Recombinant, Human Erythropoietin (rhEPO) on Oral Iron Absorption in Adult Participants With Anemia Associated With Chronic Kidney Disease Who Are [NCT03457701]Phase 215 participants (Actual)Interventional2019-07-30Completed
The Effect of Zinc on Iron Bioavailability From Fortified Extruded Rice Fortified With Ferric Pyrophosphate[NCT02255942]20 participants (Actual)Interventional2015-04-30Completed
Outcome of Oral Lactoferrin in Comparison to Amino Acid Chelated Iron and Ferrous Sulphate Supplementation During Pregnancy: A Randomized Control Trial[NCT03542825]Phase 4300 participants (Actual)Interventional2018-01-01Completed
[NCT01864161]Phase 4100 participants (Actual)Interventional2011-10-31Completed
The Effect of Prebiotics on Iron Absorption in Women With Low Iron Stores: Determination of a Dose-dependent Effect of Galacto-oligosaccharides on Iron Absorption, With and Without Addition of Ascorbic Acid[NCT03762148]46 participants (Actual)Interventional2019-04-01Completed
Treatment of Iron Defieciency Anemia[NCT02957643]Phase 1/Phase 250 participants (Actual)Interventional2016-11-30Completed
Intravenous Iron Isomaltoside Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy: A Randomized Comparative Trial[NCT05251493]Phase 3280 participants (Anticipated)Interventional2022-06-06Recruiting
A Randomized Control Trial of the Lucky Iron Fish to Improve Hemoglobin Concentration in Women in Preah Vihear, Cambodia[NCT02341586]340 participants (Actual)Interventional2015-04-30Completed
EXPLorative Data Collection for Patient chAracterIzation, treatmeNt Pathways and Outcomes of IRON Preparations[NCT03382275]51 participants (Actual)Observational [Patient Registry]2018-01-16Completed
16 Weeks' Dietary Supplementation With Iron and Iron + Vitamin C on Cerebral Blood Flow and Energy Expenditure in Women of Reproductive Age[NCT04477018]78 participants (Actual)Interventional2017-11-11Completed
Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children: A Randomized Clinical Trial[NCT00822380]680 participants (Actual)Interventional2003-03-31Completed
The Optimization of Bioavailability From Iron Supplements: Examinations of Different Supplementation Regimens Including Hepcidin Profiles[NCT02175888]20 participants (Actual)Interventional2015-10-31Completed
Scaling-up High-impact Micronutrient Supplementation Interventions to Improve Adolescents' Nutrition and Health in Burkina Faso[NCT04657640]Phase 32,100 participants (Anticipated)Interventional2020-12-11Active, not recruiting
Daily vs Alternate Day Iron Supplementation for Pregnant Women With Iron Deficiency Anemia: A Randomized Controlled[NCT03562143]88 participants (Actual)Interventional2018-08-31Completed
Efficacy Evaluation of 16 Weeks' Dietary Supplementation With Iron Bis-glycinate Plus Vitamin C on Cognitive Function, Subjective Mood, Fatigue, Health and Well-being in Non-anaemic Iron Deficient and Iron Sufficient Women of Reproductive Age[NCT04469010]151 participants (Actual)Interventional2017-06-02Completed
Effects Intravenous Iron and Oral Iron Therapy on Erythropoietin Dose in Maintenance Hemodialysis Patients: An Open-label, Randomized, Controlled Study[NCT04464850]Phase 3124 participants (Anticipated)Interventional2020-07-29Recruiting
Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia (CIA)(PK-CIA-04)[NCT01213979]Phase 116 participants (Actual)Interventional2012-02-29Completed
Iron Absorption From Iron-fortified Infant Formula and Iron Drops in Infants (MJAU-studien)[NCT01216709]72 participants (Actual)Interventional2010-10-31Completed
Iron Bioavailability From Fortified Cereal in Malawian Infants[NCT03754543]30 participants (Actual)Interventional2019-01-31Completed
Randomized Open Comparative Trial of Oral Sucrosomial Iron (SiderAl Forte®) and Oral Iron Sulphate (Duroferon®) to Blood Donors.[NCT05678647]120 participants (Anticipated)Interventional2023-01-31Recruiting
A Dose Ranging Study of Dialysate Containing Soluble Ferric Pyrophosphate (SFP) Versus Control in Subjects With ESRD Receiving Chronic Hemodialysis.[NCT00548249]Phase 2131 participants (Actual)Interventional2007-08-31Completed
The Effects of a Dietary Iron Program on Iron Status and Cognitive Function Amoung School Children in Phatthalung Province, Southern Thailand[NCT05878379]34 participants (Actual)Interventional2018-05-02Completed
The Effectiveness of Single Versus Double Daily Dose of Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant Women[NCT04101461]230 participants (Actual)Interventional2019-10-01Completed
Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation[NCT04475887]Phase 460 participants (Anticipated)Interventional2020-07-23Recruiting
Effects of Early Parenteral Iron Combined Erythropoietin in Preterm Infants[NCT02060851]Phase 496 participants (Actual)Interventional2014-02-28Completed
Doubling the Iron Dose VS Single Dose Iron Supplementation to Prevent Iron Deficiency Anemia (IDA) in Twin Pregnant Women: A Randomized Controlled Trial[NCT03836703]Phase 4450 participants (Actual)Interventional2019-02-01Completed
Effect of Infant Formula With Bovine Lactoferrin and Low Iron Concentration on Infant Health and Immune Function[NCT02103205]252 participants (Actual)Interventional2014-06-30Active, not recruiting
Preoperative, Single-dose Intravenous Iron Formulation to Reduce Post-surgical Complications in Patients Undergoing Major Abdominal Surgery: a Pilot Randomised Control Trial (PIRCAS Trial - Pilot)[NCT03295851]Phase 460 participants (Anticipated)Interventional2017-11-22Recruiting
Comparison of Home Fortification With Two Iron Formulations in Kenyan Children Protected Against Malaria by Artemisinin-based Combination Therapy: a Placebo-controlled Non-inferiority Trial[NCT02073149]Phase 2/Phase 3338 participants (Actual)Interventional2014-06-30Completed
A Randomized, Double-blind, Parallel, Three-arms, Placebo-controlled, Safety and Efficacy Study of Botanical Extract Standardized for Iron + Vitamin C and Botanical Extract Standardized for Iron in Adult Human Subjects With Anemia or Iron-deficiency Anemi[NCT06096103]96 participants (Anticipated)Interventional2023-11-15Not yet recruiting
The Optimization of Bioavailability From Iron Supplements: Examinations of Different Supplementation Regimens Including Hepcidin Profiles[NCT02177851]20 participants (Actual)Interventional2015-06-30Completed
Phase II Multiple-Dose Treatment of New Onset Type 1 Diabetes Mellitus With Anti-CD3 mAb[NCT00129259]Phase 283 participants (Actual)Interventional2005-09-30Completed
Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas[NCT03897673]600 participants (Anticipated)Interventional2019-09-01Enrolling by invitation
Do Oral Contraceptives Protect Against Anterior Cruciate Ligament Injuries in Female Athletes[NCT04899778]Phase 4100 participants (Anticipated)Interventional2021-09-29Recruiting
Physiology Study Investigating the Effects of Supplementation and Depletion of Iron on Hypoxia-related Pulmonary Hypertension[NCT00952302]33 participants (Actual)Interventional2008-10-31Completed
A Randomized, Open-Label, Single-Dose, Parallel-Design, Bioequivalence Study of Hospira Iron Sucrose Injection Compared to Venofer® Injection USP in Healthy Subjects.[NCT00719459]Phase 160 participants (Actual)Interventional2008-06-30Completed
Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] Dose Escalation Study for the Treatment of Advanced Solid Tumors: Phase 1 Clinical Trial[NCT06048367]Phase 124 participants (Anticipated)Interventional2022-10-14Recruiting
A Prospective, Randomized, Multi-centered Trial to Compare the Efficacy and Safety of Intravenous Iron Sucrose (Venoferrum®) With Oral Iron Acetyl-transferrin Hydroglycerin (Bolgre®) in Pregnant Women With Iron Deficiency Anemia[NCT00802139]Phase 458 participants (Actual)Interventional2008-02-29Completed
Rationale and Design of Ferric Polymaltose Hydroxide and Iron Sucrose Evaluation on Performance and Oxydative Stress in Patient With Iron deficIency and Stable Heart Failure Study[NCT04225728]Phase 445 participants (Actual)Interventional2017-12-01Completed
Efficacy and Safety of Parenteral Nutrition With Iron Sucrose for Anemia in Preterm Infants: a Randomized, Double-blind Controlled Study[NCT02743572]129 participants (Actual)Interventional2015-09-30Completed
Maternal Iron Absorption and Utilization and Iron Transfer to the Fetus During Pregnancy in Normal Weight and Overweight/Obese Women and the Effects on Infant Iron Status[NCT02747316]83 participants (Actual)Interventional2016-02-29Completed
The Iron Content of Ferritin in Serum and Urine of Children With High Serum Ferritin Levels[NCT03777904]11 participants (Actual)Observational2019-02-21Terminated(stopped due to Analysis of first 11 subjects resulted in values that were too varied to make the study feasible.)
Randomized Trial of Higher-dose Iron (60 mg, 45 mg) Compared to Low-dose Iron (30 mg) in Multiple Micronutrient Supplements in Pregnancy on Moderate and Severe Maternal Anemia[NCT06079918]Phase 36,381 participants (Anticipated)Interventional2023-11-30Not yet recruiting
Testing Iron Absorption From a New Micronutrient Powder Containing Galacto-oligosaccharides (GOS) for Fortification of Infant Foods in Sub-Saharan Africa[NCT02666417]64 participants (Actual)Interventional2016-01-31Completed
Acceptability and Feasibility of Micronutrient Powders Versus Iron Syrup for Anemia Prevention in Young Children[NCT02610881]110 participants (Actual)Interventional2015-12-31Completed
Phase IV Randomized Study Evaluating Agents Stimulants Erythropoiesis (ASE) Associated With Ferric Carboxymaltose (Ferinject ®) in Concomitant or Sequential Patients Treated for Cancer and With Anemia Associated With Functional Iron Deficiency[NCT02213653]Phase 424 participants (Actual)Interventional2013-04-30Terminated
Identification of Sentinel Lymph Nodes by Ultrasound Utilizing Iron Tracer Injection and Preoperative Biopsy in Women With Breast Cancer[NCT02610920]Early Phase 10 participants (Actual)Interventional2015-12-31Withdrawn(stopped due to Unable to enroll subjects)
Effect of Intravenous Iron Supplementation in Reducing Allogenic Blood Transfusion and Improving Outcomes in Patients Undergoing CABG. A Prospective Randomized Trial[NCT04061655]Early Phase 180 participants (Actual)Interventional2019-09-20Completed
Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors : a Randomized Controlled Trial[NCT00689793]Phase 4154 participants (Actual)Interventional2008-11-30Completed
Non-invasive Optical Detection of Iron Deficiency in Children- Evaluation of a Fiber Optic Tissue Fluorescence Measurement to Determine the Erythrocyte Zinc Protoporphyrin-IX/Heme Ratio[NCT02701309]100 participants (Actual)Observational2016-04-30Completed
Effects of a Commercially-available, Low-dose Iron Supplement (BloodBuilder®/Iron Response®) on Markers of Iron Status Among Premenopausal and Non-anemic, Iron-deficient Women[NCT02683369]Phase 2/Phase 323 participants (Actual)Interventional2016-02-29Completed
An Open, Randomized, Controlled, Parallel Group, Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate Together With a Randomized Placebo Controlled Double Blind Fermagate Comparison in Hemodialysis Patients With Hype[NCT00841126]Phase 3657 participants (Anticipated)Interventional2009-07-31Terminated
Combination With Intravenous Iron Supplementation or Doubling Erythropoietin Dose for Patients With Chemotherapy-induced Anaemia Inadequately Responsive to Initial Erythropoietin Treatment Alone[NCT02731378]Phase 4603 participants (Anticipated)Interventional2016-12-31Not yet recruiting
Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure[NCT00992823]99 participants (Actual)Interventional2006-03-31Completed
Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh[NCT00860470]Phase 344,567 participants (Actual)Interventional2008-01-31Completed
Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Iron Doseages During Pregnancy in Tanzania[NCT06069869]Phase 3156 participants (Anticipated)Interventional2025-09-30Not yet recruiting
Lactoferrin With Iron Versus Iron Alone in Treatment of Anemia In Chronic Liver Disease[NCT04335058]130 participants (Anticipated)Interventional2020-01-01Recruiting
Efficacy of Intravenous Ferric Carboxymaltose in the Improvement of Anemia in Patients With Postoperative Knee Prosthesis[NCT01913808]Phase 4122 participants (Actual)Interventional2011-01-31Completed
Individually Randomized Trial of Higher-dose Iron (60 mg, 45 mg) Compared to Low-dose Iron (30 mg) in Multiple Micronutrient Supplements in Pregnancy on Moderate and Severe Maternal Anemia- MMS Versus IFA Crossover Trial[NCT06069856]Phase 3130 participants (Anticipated)Interventional2025-09-30Not yet recruiting
Study of the Effects of Iron Supplementation on High Altitude Pulmonary Hypertension.[NCT00960921]Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to Study never started.)
A Randomised Controlled Trial Comparing the Efficacy of Intravenous Iron Sucrose and Oral Iron Sulfate in Patients With Iron Deficiency.[NCT01067547]Phase 4130 participants (Actual)Interventional2010-03-31Completed
Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation[NCT01047098]114 participants (Actual)Interventional2008-10-31Completed
A Clinical Pharmacological Study to Evaluate the Effects of Iron Supplements on the Pharmacokinetics of MT-6548 in Healthy Male Volunteers[NCT03645863]Phase 361 participants (Actual)Interventional2018-08-27Completed
Evaluation of the Effect of Body Weight and Composition on Iron Absorption and Blood Volume[NCT01884506]64 participants (Actual)Interventional2013-06-30Completed
Phase III Randomized Double Blind Placebo-Controlled Study To Assess The Effects Of FeraMax When Administered Orally Once A Day On Postoperative Fatigue Levels In Patients Following Elective Coronary Artery Bypass Graft Surgery (CABG)[NCT01912261]Phase 3121 participants (Actual)Interventional2014-12-16Terminated(stopped due to The study was stopped due to time constraints and resources)
Delivery of Iron and Zinc Supplements: Evaluation of Interaction Effect on Biochemical and Clinical Outcomes[NCT00470158]Phase 41,000 participants (Actual)Interventional2007-05-31Completed
Iron Isomaltoside 1000 in Patients With Iron Deficiency or Iron Deficiency Anemia: a Multicentric, Prospective, Longitudinal, Observational Study in Switzerland.[NCT04318405]327 participants (Actual)Observational2020-07-10Completed
Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From Lipid Nutrient Supplements Added to Complementary Foods[NCT01991626]47 participants (Actual)Interventional2013-09-30Completed
Comparison Between Aminoacid Chelated Iron and Iron Salt in Treatment of Iron Deficiency Anemia With Pregnancy[NCT02005588]Early Phase 1150 participants (Actual)Interventional2013-12-31Completed
An Open-label, Randomised, Active Controlled Multi-center Phase II Dose Finding Study to Evaluate the Ability of PA21 to Lower Serum Phosphate Levels and the Tolerability in Patients With Chronic Kidney Disease on Maintenance Hemodialysis[NCT00824460]Phase 2154 participants (Actual)Interventional2008-12-31Completed
Comparative Cross-over Study to Evaluate the Rate and the Extent of Iron Absorption of a New Iron Supplement (With Orodispersible Formulation) vs an Iron Supplement in Capsules, After Administration of a Single Dose in Healthy Volunteers[NCT05660200]9 participants (Actual)Interventional2022-11-25Completed
Randomized, Parallel Group, Clinical Trial Comparing Intravenous Iron Sucrose Versus Oral Ferrous Sulphate in the Treatment of Perioperative Iron Deficiency in Patients With Colo-Rectal Neoplasm and Iron Deficiency Anemia.[NCT00199277]Phase 4150 participants InterventionalNot yet recruiting
[NCT02858505]Phase 2120 participants (Actual)Interventional2015-08-31Completed
Evaluation of the Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Iron Deficiency Anemia During Pregnancy[NCT05921968]Phase 4100 participants (Anticipated)Interventional2023-07-30Not yet recruiting
A Randomized Double-Blind Safety Comparison of Intravenous Iron Dextran Versus Iron Sucrose in an Adult Non-Hemodialysis Outpatient Population: A Pilot Study[NCT00593619]Phase 4200 participants (Anticipated)Interventional2008-01-31Suspended(stopped due to Interim Analysis and review by Data Safety Monitoring Board)
A Randomized, Open-Label, Wait-list Control Trial To Evaluate the Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia and a Serum Ferritin Between 20 and 200 ng/mL[NCT01309659]Phase 219 participants (Actual)Interventional2011-05-31Terminated(stopped due to Lack of Enrollment)
Effects of Intermittent Iron and Vitamin A Supplementation on Nutritional Status and Development of Schoolchildren in Arba Minch Zuria District, Ethiopia.[NCT04137354]504 participants (Actual)Interventional2020-11-02Completed
Teff (Eragrostis Tef) as a Functional Food for the Prevention of Pregnancy Iron-deficiency Anemia[NCT01055431]Phase 155 participants (Actual)Interventional2009-10-31Completed
Comparison of Iron Absorption From Extruded FePP-fortified Rice Containing Different Zinc Compounds, Citric Acid/Trisodium Citrate and Sodium EDTA[NCT02714075]30 participants (Actual)Interventional2016-04-30Completed
Randomized Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants[NCT01125163]150 participants (Actual)Interventional2010-05-31Completed
Randomized Controlled Trial of Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis[NCT05225545]Phase 330 participants (Anticipated)Interventional2019-11-04Recruiting
Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts[NCT00613717]2,371 participants (Actual)Interventional2009-11-30Completed
The Role of Sub-clinical Inflammation on the Iron Status of Myanmar Anaemic Adolescent Schoolgirls During Iron and Vitamin A Supplementation[NCT01198574]Phase 3402 participants (Actual)Interventional2010-07-31Completed
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia[NCT00236977]Phase 3182 participants (Actual)Interventional2003-08-31Completed
Iron-Deficiency Anemia in Infants: Comparative Study of Two Weekly Supplement Programs[NCT00655408]130 participants (Actual)Interventional2003-04-30Completed
Monthly Itraconazole Versus Classic Homeopathy for the Treatment of Recurrent Vulvovaginal Candidiasis: a Randomised Trial[NCT00895453]144 participants (Actual)Interventional2000-05-31Completed
Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls[NCT01490944]Phase 2360 participants (Anticipated)Interventional2012-01-31Recruiting
Randomized Trial Comparing Intravenous Iron Carboxymaltose, Intravenous Iron Isomaltoside and Oral Iron Sulphate for Postpartum Anemia[NCT03957057]Phase 3300 participants (Actual)Interventional2020-09-10Completed
Swiss Functional Iron Deficiency Study[NCT00495781]77 participants (Actual)Interventional2004-10-31Completed
Assessment of the Bioavailability of Iron in Iron Fortified Bouillon Cubes in Healthy Nigerian Women[NCT02815449]24 participants (Actual)Interventional2017-05-08Completed
Iron Metabolism in Small Pre Term Newborns[NCT01443195]50 participants (Anticipated)Interventional2011-10-31Active, not recruiting
Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty: a Randomized Controlled Trial[NCT01857011]Phase 356 participants (Actual)Interventional2014-04-30Completed
A Pilot Study Comparing Tolerance of Oral Heme Iron Polypeptide With Oral Ionic Iron[NCT01865175]Phase 40 participants (Actual)Interventional2016-01-31Withdrawn(stopped due to Institution required IND, although FDA did not, so institution did not allow enrollment)
A Phase 2, Randomized, Open-Label, Dose Titration, Safety and Efficacy Study of FG-4592 for the Correction of Anemia in Newly Initiated Dialysis Patients Not on Erythropoiesis-Stimulating Agent Treatment[NCT01414075]Phase 260 participants (Actual)Interventional2011-07-21Completed
Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial[NCT03830034]Phase 4150 participants (Anticipated)Interventional2019-02-02Recruiting
Evaluation of Iron Absorption From Ferric Ammonium Phosphate and Ferric Pyrophosphate From an Instant Milk Drink in Young Children[NCT05642689]40 participants (Actual)Interventional2009-11-30Completed
Sucrosomial Iron Supplementation in Anaemic Patients With Celiac Disease Not Tolerating Oral Ferrous Sulfate[NCT02916654]20 participants (Anticipated)Interventional2015-04-30Recruiting
HiFIT Study: Interest of Intravenous Iron and Tranexamic Acid to Reduce Transfusion in Hip Fracture Patients[NCT02972294]Phase 3419 participants (Actual)Interventional2017-03-31Terminated(stopped due to 1year inclusion hold due to PV new fact (Monofer hold for risk revaluation) DSMB Interim analysis : 1treatment with important transfusion risk reduction/inclusions issues (COVID)/sites change of practice if study continue=>stop inclusions)
Effects of Oral Iron Supplementation Before vs. at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women[NCT05919472]180 participants (Anticipated)Interventional2023-07-01Recruiting
Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months[NCT00269542]94,359 participants (Actual)Interventional2002-02-28Completed
Meals to Improve Absorption of Iron Supplements and Iron Status in Iron Deficient Women of Reproductive Age: a Randomized, Controlled Trial[NCT04793906]80 participants (Anticipated)Interventional2021-05-10Recruiting
A Single-center, Double-blinded, Randomized, 12 Week, Superiority Study in Infants and Young Children to Compare the Efficacy of NovaFerrum® Versus Ferrous Sulfate in the Treatment of Nutritional Iron Deficiency Anemia.[NCT01904864]Phase 480 participants (Actual)Interventional2013-07-31Completed
Assessment of Complementary Feeding of Canadian Infants[NCT01790542]87 participants (Actual)Interventional2012-12-31Completed
Randomized Controlled Study of Iron Supplementation to Support the Response to Recombinant Human Erythropoietin for the Treatment of Chemotherapy-Induced Anaemia[NCT00482716]Phase 380 participants (Anticipated)Interventional2007-01-31Active, not recruiting
Double-blind Comparator of Efficacy of Oral (Ferrous Sulfate) vs. Intravenous Iron (Ferumoxytol) for Treatment of the Restless Legs Syndrome (RLS) Occurring With Iron Deficient Anemia (IDA)[NCT02499354]Phase 2100 participants (Actual)Interventional2014-08-31Completed
Evaluation of the Validity of a Novel Isotope Dilution Method to Assess the Iron Status and Its Changes in Swiss Women[NCT02979132]60 participants (Anticipated)Interventional2017-09-01Active, not recruiting
An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 Compared With Sevelamer Carbonate Followed by a Randomised Comparison of PA21 Maintenance Dose Versus PA21-Low Dose in [NCT01324128]Phase 31,059 participants (Actual)Interventional2011-03-31Completed
Iron Sucrose Combined With rHuEPO and Ascorbic Acid on Perioperative Allogeneic Red Blood Cell Infusion in Patients Undergoing Elective Major Cardiac Surgery[NCT05353348]370 participants (Anticipated)Interventional2023-02-15Recruiting
Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease[NCT02949765]35 participants (Anticipated)Interventional2015-12-31Recruiting
Safe and Effective Delivery of Supplemental Iron to Healthy Volunteers[NCT03212677]224 participants (Anticipated)Interventional2017-05-17Recruiting
Study to Measure the Absorption of Iron From Ferrous Gluconate Incorporated Into Alginate Beads.[NCT01528644]16 participants (Actual)Interventional2012-02-29Completed
The Value of Iron Treatment for Postoperative Obstetric Patients With Anemia: a Randomized Double Blind Controlled Trial[NCT01975272]Phase 427 participants (Actual)Interventional2015-03-02Terminated(stopped due to Disapointing randomization rate)
A Randomized, Controlled, Double Blinded Clinical Trial of Intravenous Iron Sucrose in Adolescents With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)[NCT01978535]Phase 1/Phase 23 participants (Actual)Interventional2014-12-17Terminated(stopped due to Difficulty in recruiting subjects.)
Testing Iron Absorption From a New Micronutrient Powder Containing Galacto-oligosaccharides (GOS) for Fortification of Infant Foods in Sub-Saharan Africa[NCT02989311]23 participants (Actual)Interventional2016-08-31Completed
Monocentric, Prospective, Randomized Study to Evaluate the Efficacy of a New Iron Supplement With Orodispersible Formulation vs an Iron Supplement in Capsules in Subjects With Mild Anemia[NCT05989984]60 participants (Anticipated)Interventional2023-08-04Recruiting
A Phase III, Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of PGL4001 (Ulipristal) Versus Placebo for Pre-Operative Treatment of Symptomatic Uterine Myomas[NCT00755755]Phase 3241 participants (Actual)Interventional2008-10-31Completed
ANEMEX UK Trial: Artificial Intelligence for Optimal Anemia Management in End-stage Renal Disease: The Anemia Control Model (ACM) Trial[NCT03214627]88 participants (Actual)Interventional2018-12-10Terminated(stopped due to Standard clinical practice at site caused unforeseen issues for the use of the ACM)
Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Moderate to Severe Iron Deficient Anemia of Pregnancy in Women Intolerant of or Responsive to Oral Iron.[NCT02038023]Phase 274 participants (Actual)Interventional2013-07-31Completed
Prevention of Iron Deficiency Anemia Post-delivery (PRIORITY Trial): A Randomized Controlled Trial of the Global Network for Women's and Children's Health Research[NCT05590260]Phase 34,800 participants (Anticipated)Interventional2023-05-30Recruiting
Comparison of the Safety and Efficacy of Three Iron Sucrose Maintenance Regimens in Pediatric Chronic Kidney Disease (CKD) Patients[NCT00239642]Phase 4141 participants (Actual)Interventional2005-07-31Completed
Comparison of Iron Absorption From Regular-iron, Iron Biofortified, and Post-harvest Iron-fortified Pearl Millet Using Multiple Meals in Young Women[NCT01634932]22 participants (Actual)Interventional2012-07-31Completed
[NCT01733979]80 participants (Actual)Interventional2012-02-07Completed
Acute vs. Delayed Iron: Effect on Red Cell Iron Incorporation in Severe Malaria[NCT01754701]100 participants (Actual)Interventional2013-06-30Completed
Chelated Oral Iron Versus Intravenous Iron Sucrose for Treatment of Iron Deficiency Anemia Late in Pregnancy ( Randomized Controlled Trial )[NCT05151679]0 participants Expanded AccessAvailable
Is Iron Deficiency the Cause of Anemia Among Women of Reproductive Age in Cambodia? A 2 x 2 Factorial Double Blind Randomized Controlled Trial of Oral Iron and Multiple Micronutrient Supplementation[NCT02481375]809 participants (Actual)Interventional2015-07-31Completed
Defining the Functional and Metabolic Role of Iron in Aerobic Training and Physical Performance[NCT03002090]109 participants (Actual)Interventional2014-08-31Completed
Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease[NCT02151643]Phase 2153 participants (Actual)Interventional2014-05-07Completed
A Randomised Phase II Trial of Iron Isomaltide Versus Oral Iron Supplement for Radiotherapy or Chemotherapy Associated Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma[NCT05913414]Phase 2120 participants (Anticipated)Interventional2023-05-05Recruiting
Role of Iron, Alpha-Synuclein, and Lymphocyte-activation Gene-3 in the Pathophysiology of Ischemic Stroke in Human and Albino Rats[NCT05748587]48 participants (Anticipated)Observational2023-04-01Recruiting
A Comparison Between Intravenous Iron Sucrose to Its Combination With Oral Iron Supplements for the Treatment of Postpartum Anemia[NCT02458625]158 participants (Actual)Interventional2016-04-30Completed
Zinc, Iron and Vitamin A Supplementation for Infant Growth and Development, and the Contributing Role of Psychosocial Care[NCT02319499]Phase 3800 participants (Actual)Interventional1998-08-31Completed
Erythropoietin to Prevent Unnecessary Transfusions In Patients With Cyanotic Congenital Heart Disease - A Prospective Randomized Control Trial[NCT02564796]Phase 24 participants (Actual)Interventional2016-11-30Terminated(stopped due to COVID)
Nutri-CAP: Nutrition for Children, Adolescent Girls, and Pregnant Women in Slums of Dhaka City[NCT05311436]3,260 participants (Anticipated)Interventional2022-07-01Recruiting
Efficacy and Safety of Perioperative Iron Supplementation for Postoperative Rehabilitation of Geriatric Hip Fractures: a Multicenter, Randomized, Controlled Trial.[NCT05489952]Phase 4444 participants (Anticipated)Interventional2022-09-15Recruiting
A Randomised, Double-blinded, Parallel Group Study to Demonstrate the Adherence and Efficacy of Different Doses of Iron Supplement in Subjects With or At-risk of Iron Deficiency With a History of Intolerance to Oral Iron[NCT04778072]60 participants (Anticipated)Interventional2018-10-08Active, not recruiting
Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease[NCT05456932]Phase 490 participants (Anticipated)Interventional2022-08-19Recruiting
Prospective Study of Iron Deficiency Anemia in Twin Pregnancy[NCT04975074]Phase 41,000 participants (Anticipated)Interventional2021-07-15Not yet recruiting
Randomized, Double-blind, Community-based Efficacy Trial of Various Doses of Zinc in Micronutrient Powders or Tablets in Young, Bangladeshi Children[NCT03406793]2,886 participants (Actual)Interventional2018-02-20Completed
Interactions of Lead Intoxication and Iron Deficiency in Morocco: The Effects of Iron Fortification With and Without NaEDTA on Lead Burden, Iron Status and Cognition in Children[NCT01573013]457 participants (Actual)Interventional2011-09-30Completed
Trial of Darbepoetin Plus Slow-release Intravenous Iron to Decrease Transfusions and Improve Iron Status and Neurodevelopment in Preterm Infants[NCT05340465]Phase 2120 participants (Anticipated)Interventional2022-11-27Recruiting
A Phase III, Randomized, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemother[NCT01145638]Phase 3350 participants (Actual)Interventional2010-10-31Completed
The Effects of Intravenous Iron Therapy for Anemia Correction in Patients With Severe Chronic Heart Failure and Concomitant Moderate Chronic Kidney Disease[NCT00384657]Phase 30 participants (Actual)Interventional2008-01-31Withdrawn(stopped due to Lack of cooperation among centers, Financial reasons)
FLIPS: Ferfer Liposomal Iron Performance Study[NCT03112187]Phase 4400 participants (Actual)Interventional2017-08-01Completed
A Phase III, Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose in Subjects With Iron Deficiency Anaemia and Who Are Intolerant or Unresponsive to Oral Iron Therapy or Who Need Iron Rapidly (PROVIDE[NCT02130063]Phase 3511 participants (Actual)Interventional2014-05-31Completed
Iron Bioavailability From Fortified Food in Healthy Women[NCT02993835]23 participants (Actual)Interventional2016-12-31Completed
Heme Iron Polypeptide for the Treatment of Iron Deficiency Anemia in Pre-Dialysis Patients: A Pilot Randomized Controlled Study[NCT00318812]Phase 2/Phase 355 participants (Actual)Interventional2007-05-31Completed
Iron Sucrose In The Treatment of Restless Legs Syndrome (RLS): The Safety of Three Dose Regimens as Evaluated by Clinical Assessments[NCT00895232]Phase 221 participants (Actual)Interventional2003-11-30Completed
Enteral Iron Supplementation and Intestinal Health in Preterm Infants[NCT04497012]Phase 4183 participants (Anticipated)Interventional2020-11-17Recruiting
Daily vs. Every Other Day Oral Iron Supplementation in Patients With Absolute Iron Deficiency Anemia (DEODO): a Multi-centered, Pilot Randomized Controlled Trial[NCT03725384]Phase 352 participants (Actual)Interventional2019-01-04Completed
Effectiveness of Quadruple Fortified Salt in Improving Hemoglobin Levels Among Anemic Women of Reproductive Age (18-49 Years) in Rural Low Resource Setting[NCT04404751]174 participants (Actual)Interventional2019-08-23Completed
Clinical Observation of The Gynecological Iron-Deficiency Anemia Treated With Buxue Yimu Pills[NCT03232554]Phase 2180 participants (Anticipated)Interventional2017-06-01Recruiting
Oral Iron Repletion Effects On Oxygen Uptake in Heart Failure[NCT02188784]Phase 3225 participants (Actual)Interventional2014-09-03Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change in Hemoglobin (Hb) From Baseline to Week 8

"Efficacy~Evaluate the effect on the hemoglobin (Hb) level following treatment with iron isomaltoside/ferric derisomaltose vs iron sucrose in subjects with iron deficiency anaemia (IDA) .~Response was defined as change from baseline in hemoglobin (Hb) to week 8, i.e. ability to increase Hb in subjects with IDA, when oral iron preparations were ineffective or could not be used or in whom the screening Hb measurement in Investigators' opinion were sufficiently low to require rapid repletion of iron stores." (NCT02940886)
Timeframe: Baseline to week 8

Interventiong/dL (Least Squares Mean)
Iron Isomaltoside/Ferric Derisomaltose2.49
Iron Sucrose2.49

Composite Cardiovascular Adverse Events (AEs)

"Safety~Results show the composite cardiovascular adverse events (AEs), that started on or after the first dose of randomised treatment (i.e. treatment emergent) up to week 8.~The reported potential cardiovascular AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).~The potential cardiovascular AEs included the following:~Death due to any cause~Non-fatal myocardial infarction~Non-fatal stroke~Unstable angina requiring hospitalisation~Congestive heart failure requiring hospitalisation or medical intervention~Arrhythmias~Hypertension~Hypotension~Results show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs." (NCT02940886)
Timeframe: Baseline, week 1, 2, and 8

InterventionParticipants (Count of Participants)
Iron Isomaltoside/Ferric Derisomaltose8
Iron Sucrose6

Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8

"Efficacy~Results show the number of participants who achieved Hb concentration increase of ≥2 g/dL at any time from week 1 to week 8." (NCT02940886)
Timeframe: Week 1 to week 8

InterventionParticipants (Count of Participants)
Iron Isomaltoside/Ferric Derisomaltose687
Iron Sucrose340

Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8

"Efficacy~Hb concentration of >12 g/dL at any time from week 1 to week 8.~Results show the number of participants who achieved Hb concentration of >12 g/dL at any time from week 1 to week 8." (NCT02940886)
Timeframe: Week 1 to week 8

InterventionParticipants (Count of Participants)
Iron Isomaltoside/Ferric Derisomaltose484
Iron Sucrose225

Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions

"Safety~For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity reactions that were included in the analysis were those that started on or after the first dose of randomised treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: loss of consciousness, seizure, syncope, unresponsiveness.~The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).~Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions." (NCT02940886)
Timeframe: Baseline to week 8

InterventionParticipants (Count of Participants)
Iron Isomaltoside/Ferric Derisomaltose3
Iron Sucrose2

Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car

"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)." (NCT02940886)
Timeframe: Baseline

Interventionmiles (Median)
Iron Isomaltoside/Ferric Derisomaltose15.0
Iron Sucrose15.0

S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8

"Efficacy~Proportion of subjects reaching the composite endpoint of s-ferritin concentration ≥100 ng/mL and TSAT of 20-50% at any time from week 1 to 8." (NCT02940886)
Timeframe: Week 1 to week 8

InterventionParticipants (Count of Participants)
Iron Isomaltoside/Ferric Derisomaltose680
Iron Sucrose164

S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8

"Safety~Results show the number of subjects who had s-phosphate <2 mg/dL at any time from baseline to week 1, 2, 4, or 8." (NCT02940886)
Timeframe: Baseline, week 1, 2, 4, and 8

InterventionParticipants (Count of Participants)
Iron Isomaltoside/Ferric Derisomaltose38
Iron Sucrose11

Time to Change in Hb Concentration ≥2 g/dL

"Efficacy~Time to change in Hb concentration ≥2 g/dL. Subjects who achieved Hb concentration increase of ≥2 g/dL (from baseline to week 1, 2, 4, or 8).~For responders, time to Hb response was defined as the scheduled time from baseline until the visit where the first Hb response was measured." (NCT02940886)
Timeframe: Baseline, week 1, 2, 4, and 8

InterventionDays (Median)
Iron Isomaltoside/Ferric Derisomaltose28
Iron Sucrose28

Time to First Composite Cardiovascular Safety AE

"Safety~Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. Only the adjudicated and confirmed composite cardiovascular safety AEs, as judged by the CEAC, were considered for this endpoint.~Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit." (NCT02940886)
Timeframe: Baseline, week 1, 2, 4, and 8

InterventionWeek (Median)
Iron Isomaltoside/Ferric DerisomaltoseNA
Iron SucroseNA

Change in Concentrations of Serum Iron (S-iron) From Baseline to Week 1, 2, 4, and 8

"Efficacy~Changes in the concentrations of serum iron (s-iron) from baseline to week 1, 2, 4, and 8." (NCT02940886)
Timeframe: Baseline, week 1, 2, 4, and 8

,
Interventionμg/dL (Mean)
Week 1Week 2Week 4Week 8
Iron Isomaltoside/Ferric Derisomaltose63.238.831.224.2
Iron Sucrose22.437.035.127.6

Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8

"Efficacy~Change in fatigue symptoms from baseline to week 1, 2, and 8 was measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.~The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale consisted of 13 items ranging from 0 (not at all) to 4 (very much), except items #7 and #8 which are reversed scored. The total score range is 0-52.~A score of less than 30 indicated severe fatigue, and the higher the score, the better outcome/quality of life (QoL). If more than 50% of the items for a subject at a given visit were missing, the total score was not calculated.~Total score was calculated as shown below:~Total score= Sum of individual scores x 13 / Number of items answered" (NCT02940886)
Timeframe: Baseline, week 1, 2, and 8

,
Interventionscore on a scale (Mean)
Week 1Week 2Week 8
Iron Isomaltoside/Ferric Derisomaltose7.9810.7414.08
Iron Sucrose7.3811.8915.36

Change in Hb Concentration From Baseline to Week 1, 2, and 4

"Efficacy~Change in Hb concentration from baseline to week 1, 2, and 4." (NCT02940886)
Timeframe: Baseline, week 1, 2, and 4

,
Interventiong/dL (Mean)
Week 1Week 2Week 4
Iron Isomaltoside/Ferric Derisomaltose0.701.492.15
Iron Sucrose0.471.252.13

Change in S-ferritin Concentration From Baseline to Weeks 1, 2, 4, and 8

"Efficacy~Change in s-ferritin concentration from baseline to weeks 1, 2, 4, and 8." (NCT02940886)
Timeframe: Baseline, week 1, 2, 4, and 8

,
Interventionng/mL (Mean)
Week 1Week 2Week 4Week 8
Iron Isomaltoside/Ferric Derisomaltose373.5211.898.049.0
Iron Sucrose105.7169.9109.258.7

Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8

"Efficacy~Changes in transferrin saturation (TSAT) from baseline to week 1, 2, 4, and 8.~TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron." (NCT02940886)
Timeframe: Baseline, week 1, 2, 4, and 8

,
Interventionpercentage of saturation (Mean)
Week 1Week 2Week 4Week 8
Iron Isomaltoside/Ferric Derisomaltose16.6812.3311.639.01
Iron Sucrose5.8410.5811.088.87

Hb Concentration Increase of ≥2 g/dL From Baseline to Week 1, 2, 4, and 8

"Efficacy~Results show responders to the treatment. A subject was considered a Hb responder to a certain week if an increase in Hb of at least 2 g/dL from baseline to the week in question was observed (week 1, 2, 4, and 8)." (NCT02940886)
Timeframe: Baseline, week 1, 2, 4, and 8

,
InterventionParticipants (Count of Participants)
Responder YES week 1Responder YES week 2Responder YES week 4Responder YES week 8
Iron Isomaltoside/Ferric Derisomaltose51297514606
Iron Sucrose1294250309

Health Care Resource Use Questionnaire

"Pharmacoeconomics~Resources used by the health care staff (per administration), measured by the health care resource use questionnaire. The questionnaire assessed the time used by the health care staff during administration of the investigational product and the administration time (including the observational time). The health care participants included in the evaluation were: investigator, pharmacist, physician, study coordinator, study nurse.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the treatment groups is different (i.e. up to a factor 5 more frequent in the iron sucrose treatment group)." (NCT02940886)
Timeframe: Baseline

,
Interventionhours (Median)
Time spent per site staff medianTime spent per subject median
Iron Isomaltoside/Ferric Derisomaltose1.083.38
Iron Sucrose1.003.00

Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking

"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)." (NCT02940886)
Timeframe: Baseline

,
InterventionUS dollars ($) (Median)
Cost of public transport/taxiCost of parking
Iron Isomaltoside/Ferric Derisomaltose5.00.0
Iron Sucrose5.00.0

Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits

"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)." (NCT02940886)
Timeframe: Baseline

,
Interventionparticipants (Number)
In employment, YESTook time off work to attend, YESAssistance by others to attend visit, YESOthers took time off work to attend, YES
Iron Isomaltoside/Ferric Derisomaltose52923321164
Iron Sucrose25811311132

Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit

"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)." (NCT02940886)
Timeframe: Baseline

,
InterventionHours (Median)
Time spent on visitTotal time spent helping on visit
Iron Isomaltoside/Ferric Derisomaltose2.02.0
Iron Sucrose2.02.0

Change From Baseline in Blood Hemoglobin Level (g/L)

Changes in blood hemoglobin level (g/L) after 12-weeks of iron-deficiency anaemia treatment, a non-inferiority comparison, as compared with the baseline value (screening visit) between Ferrum Lek® and MALTOFER® groups (NCT03993288)
Timeframe: Baseline and Week 12

Interventiong/L (Mean)
Ferrum Lek18.33
MALTOFER18.52

Number of Participants With Response to the Therapy

Response to the therapy is determined as an increase in hemoglobin level by 20 g/L and more after 12-weeks of treatment (NCT03993288)
Timeframe: Baseline and Week 12

InterventionParticipants (Count of Participants)
Ferrum Lek59
MALTOFER56

Change From Baseline in Ferritin

Change in average values of iron metabolism parameter ferritin during the treatment period (NCT03993288)
Timeframe: Baseline, Week 4, 8 and 12

,
Interventionmicrogram/liter (Mean)
Week 4Week 8Week 12
Ferrum Lek3.484.97.62
MALTOFER7.354.496.55

Change From Baseline in Percent Transferrin Saturation

Change in average values of iron metabolism parameter percent transferrin saturation during the treatment period (NCT03993288)
Timeframe: Baseline, Week 4, 8 and 12

,
Interventionpercent transferrin saturation (Mean)
Week 4Week 8Week 12
Ferrum Lek2.468.257.27
MALTOFER4.445.478.03

Change From Baseline in Serum Iron

Change in average values of iron metabolism parameter serum iron during the treatment period (NCT03993288)
Timeframe: Baseline, Week 4, 8 and 12

,
Interventionmicromoles/liter (Mean)
Week 4Week 8Week 12
Ferrum Lek1.764.095.16
MALTOFER3.424.346.12

Change From Baseline in Transferrin

Change in average values of iron metabolism parameter transferrin during the treatment period (NCT03993288)
Timeframe: Baseline, Week 4, 8 and 12

,
Interventiong/L (Mean)
Week 4Week 8Week 12
Ferrum Lek-0.15-0.22-0.24
MALTOFER-0.14-0.22-0.25

Change in Hemoglobin (Hb) From Baseline to Week 8

"Efficacy~Evaluate the effect of iron isomaltoside/ferric derisomaltose vs iron sucrose in subjects with non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).~Response was defined as change from baseline in hemoglobin (Hb) to week 8, i.e. ability to increase Hb in subjects with NDD-CKD and IDA, when oral iron preparations were ineffective or could not be used, or in whom the Hb measurement at screening in Investigators' opinion were sufficiently low to require rapid repletion of iron stores." (NCT02940860)
Timeframe: Baseline to week 8

Interventiong/dL (Least Squares Mean)
Iron Isomaltoside/Ferric Derisomaltose1.22
Iron Sucrose1.14

Composite Cardiovascular Adverse Events (AEs)

"Safety~Results show the composite cardiovascular AEs, that started on or after the first dose of randomised treatment (i.e. treatment emergent) up to week 8.~The reported potential cardiovascular AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).~The potential cardiovascular AEs included the following:~Death due to any cause~Non-fatal myocardial infarction~Non-fatal stroke~Unstable angina requiring hospitalisation~Congestive heart failure requiring hospitalisation or medical intervention~Arrhythmias~Hypertension~Hypotension~Results show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs." (NCT02940860)
Timeframe: Baseline, week 1, 2, and 8

InterventionParticipants (Count of Participants)
Iron Isomaltoside/Ferric Derisomaltose42
Iron Sucrose35

Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8

"Efficacy~Results show the number of participants who achieved Hb concentration increase of ≥2 g/dL at any time from week 1 to week 8." (NCT02940860)
Timeframe: Week 1 to week 8

InterventionParticipants (Count of Participants)
Iron Isomaltoside/Ferric Derisomaltose307
Iron Sucrose133

Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8

"Efficacy~Hb concentration of >12 g/dL at any time from week 1 to week 8.~Results show the number of participants who achieved Hb concentration of >12 g/dL at any time from week 1 to week 8." (NCT02940860)
Timeframe: Week 1 to week 8

InterventionParticipants (Count of Participants)
Iron Isomaltoside/Ferric Derisomaltose259
Iron Sucrose121

Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions

"Safety~For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity reactions that were included in the analysis were those that started on or after the first dose of randomised treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: loss of consciousness, seizure, syncope, unresponsiveness.~The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).~Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions." (NCT02940860)
Timeframe: Baseline to week 8

InterventionParticipants (Count of Participants)
Iron Isomaltoside/Ferric Derisomaltose3
Iron Sucrose0

Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car

"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)." (NCT02940860)
Timeframe: Baseline

Interventionmiles (Median)
Iron Isomaltoside/Ferric Derisomaltose19.0
Iron Sucrose18.0

S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8

"Efficacy~Proportion of subjects reaching the composite endpoint of s-ferritin concentration ≥100 ng/mL and TSAT of 20-50% at any time from week 1 to 8." (NCT02940860)
Timeframe: Week 1 to week 8

InterventionParticipants (Count of Participants)
Iron Isomaltoside/Ferric Derisomaltose873
Iron Sucrose388

S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8

"Safety~Results show the number of participants who had s-phosphate <2 mg/dL at any time from baseline to week 1, 2, 4, or 8." (NCT02940860)
Timeframe: Baseline, week 1, 2, 4, and 8

InterventionParticipants (Count of Participants)
Iron Isomaltoside/Ferric Derisomaltose32
Iron Sucrose4

Time to Change in Hb Concentration ≥1 g/dL

"Efficacy~Time to change in Hb concentration ≥1 g/dL.~Subjects who showed Hb concentration increase of ≥1 g/dL (from baseline to week 1, 2, 4, and 8).~For responders, time to Hb response was defined as the scheduled time from baseline until the visit where the first Hb response was measured." (NCT02940860)
Timeframe: Baseline, week 1, 2, 4, and 8

InterventionDays (Median)
Iron Isomaltoside/Ferric Derisomaltose56
Iron Sucrose56

Time to First Composite Cardiovascular Safety AE

"Safety~Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. Only the adjudicated and confirmed composite cardiovascular safety AEs, as judged by the CEAC, were considered for this endpoint.~Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit." (NCT02940860)
Timeframe: Baseline, week 1, 2, 4, and 8

InterventionWeek (Median)
Iron Isomaltoside/Ferric DerisomaltoseNA
Iron SucroseNA

Change in Concentration of S-iron From Baseline to Week 1, 2, 4, and 8

"Efficacy~Changes in the concentrations of serum iron (s-iron) from baseline to week 1, 2, 4, and 8." (NCT02940860)
Timeframe: Baseline, week 1, 2, 4, and 8

,
Interventionμg/dL (Mean)
Week 1Week 2Week 4Week 8
Iron Isomaltoside/Ferric Derisomaltose34.811.16.57.1
Iron Sucrose11.112.410.212.4

Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8

"Efficacy~Change in fatigue symptoms from baseline to week 1, 2, and 8 was measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.~The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale consisted of 13 items ranging from 0 (not at all) to 4 (very much), except items #7 and #8 which are reversed scored. The total score range is 0-52.~A score of less than 30 indicated severe fatigue, and the higher the score, the better outcome/quality of life (QoL). If more than 50% of the items for a subject at a given visit were missing, the total score was not calculated.~Total score was calculated as shown below:~Total score= Sum of individual scores x 13 / Number of items answered" (NCT02940860)
Timeframe: Baseline, week 1, 2, and 8

,
Interventionscore on a scale (Mean)
Week 1Week 2Week 8
Iron Isomaltoside/Ferric Derisomaltose5.047.299.13
Iron Sucrose5.017.639.07

Change in Hb Concentration From Baseline to Week 1, 2, and 4

"Efficacy~Change in Hb concentration from baseline to week 1, 2, and 4." (NCT02940860)
Timeframe: Baseline, week 1, 2, and 4

,
Interventiong/dL (Mean)
Week 1Week 2Week 4
Iron Isomaltoside/Ferric Derisomaltose0.440.771.08
Iron Sucrose0.210.500.90

Change in S-ferritin From Baseline to Weeks 1, 2, 4, and 8

"Efficacy~Changes in s-ferritin from baseline to weeks 1, 2, 4, and 8." (NCT02940860)
Timeframe: Baseline, week 1, 2, 4, and 8

,
Interventionng/mL (Mean)
Week 1Week 2Week 4Week 8
Iron Isomaltoside/Ferric Derisomaltose492.4381.2258.4191.3
Iron Sucrose183.9292.4255.4187.9

Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8

"Efficacy~Changes in transferrin saturation (TSAT) from baseline to week 1, 2, 4, and 8." (NCT02940860)
Timeframe: Baseline, week 1, 2, 4, and 8

,
Interventionpercent (Mean)
Week 1Week 2Week 4Week 8
Iron Isomaltoside/Ferric Derisomaltose12.105.844.995.10
Iron Sucrose4.315.645.595.93

Hb Concentration Increase of ≥1 g/dL From Baseline to Week 1, 2, 4, and 8

"Efficacy~Results show Hb responders to the treatment. A subject was considered a Hb responder to a certain week if an increase in Hb of at least 1 g/dL from baseline to the week in question was observed (from baseline to week 1, 2, 4, and 8)." (NCT02940860)
Timeframe: Baseline, week 1, 2, 4, and 8

,
InterventionParticipants (Count of Participants)
Responder YES week 1Responder YES week 2Responder YES week 4Responder YES week 8
Iron Isomaltoside/Ferric Derisomaltose200339430474
Iron Sucrose78112174226

Health Care Resource Use Questionnaire

"Pharmacoeconomics~Resources used by the health care staff (per administration), measured by the health care resource use questionnaire.~The questionnaire assessed the time used by the health care staff during administration of the investigational product and the administration time (including the observational time). The health care participants included in the evaluation were: investigator, pharmacist, physician, study coordinator, study nurse.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different (i.e. up to a factor 5 more frequent in the iron sucrose treatment group)." (NCT02940860)
Timeframe: Baseline

,
Interventionhours (Median)
Time spent per site staffTime spent per subject
Iron Isomaltoside/Ferric Derisomaltose1.172.58
Iron Sucrose1.002.33

Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking

"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)." (NCT02940860)
Timeframe: Baseline

,
InterventionUS dollars ($) (Median)
Cost of public transport/taxiCost of parking
Iron Isomaltoside/Ferric Derisomaltose0.00.0
Iron Sucrose0.00.0

Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits

"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)." (NCT02940860)
Timeframe: Baseline

,
InterventionParticipants (Count of Participants)
In employment, YESTook time off work to attend, YESAssistance by others to attend visit, YESOthers took time off work to attend, YES
Iron Isomaltoside/Ferric Derisomaltose1527041082
Iron Sucrose572619740

Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit

"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)." (NCT02940860)
Timeframe: Baseline

,
InterventionHours (Median)
Time spent on visitTotal time spent helping on visit
Iron Isomaltoside/Ferric Derisomaltose2.002.00
Iron Sucrose2.002.00

Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO

Blood samples were collected at indicated time points for analysis of fractional oral iron absorption following treatment with Daprodustat and rhEPO. Adjusted mean and 95 percent (%) confidence interval (CI) has been presented. (NCT03457701)
Timeframe: Up to Day 57

InterventionPercentage (%) of iron absorbed (Mean)
Daprodustat20.64
rhEPO20.62

Period 1 and 2: Change From Baseline in Transferrin Following Treatment With Daprodustat or rhEPO

Blood samples were collected from participants for measurement of transferrin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)

,
InterventionGram per Liter (g/L) (Mean)
Period 1, DAY 14Period 1, DAY 28Period 2, DAY 14Period 2, DAY 28
Daprodustat0.1820.283-0.1770.138
rhEPO0.145-0.040-0.163-0.352

Periods 1 and 2: Change From Baseline in Erythrocyte Mean Corpuscular Volume Following Treatment With Daprodustat and rhEPO

Blood samples were collected from participants for measurement of erythrocyte mean corpuscular volume at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)

,
InterventionFemtoliter (fL) (Mean)
Period 1, DAY 14Period 1, DAY 28Period 2, DAY 14Period 2, DAY 28
Daprodustat-0.8-1.52.80.3
rhEPO-0.5-0.8-0.3-0.8

Periods 1 and 2: Change From Baseline in Erythrocytes Following Treatment With Daprodustat and rhEPO

Blood samples were collected from participants for measurement of erythrocytes (red blood cells number) at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)

,
Intervention10^12 cells/liter (Mean)
Period 1, DAY 14Period 1, DAY 28Period 2, DAY 14Period 2, DAY 28
Daprodustat0.05-0.13-0.17-0.13
rhEPO0.130.130.130.07

Periods 1 and 2: Change From Baseline in Erythroferrone Following Treatment With Daprodustat and rhEPO

Blood samples were collected from participants for measurement of erythroferrone at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)

,
InterventionMicrogram per liter (ug/L) (Mean)
Period 1, DAY 14Period 1, DAY 28Period 2, DAY 14Period 2, DAY 28
Daprodustat0.1350.0750.0630.032
rhEPO-0.062-0.090-0.068-0.110

Periods 1 and 2: Change From Baseline in Hematocrit Following Treatment With Daprodustat and rhEPO

Blood samples were collected from participants for measurement of hematocrit at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)

,
InterventionProportion of red blood cells in blood (Mean)
Period 1, DAY 14Period 1, DAY 28Period 2, DAY 14Period 2, DAY 28
Daprodustat0.002-0.017-0.006-0.010
rhEPO0.0110.0090.0090.002

Periods 1 and 2: Change From Baseline in Hemoglobin Following Treatment With Daprodustat and rhEPO

Blood samples were collected from participants for measurement of hemoglobin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)

,
InterventionGrams per liter (g/L) (Mean)
Period 1, DAY 14Period 1, DAY 28Period 2, DAY 14Period 2, DAY 28
Daprodustat0.7-5.0-5.3-4.3
rhEPO2.83.53.72.3

Periods 1 and 2: Change From Baseline in Reticulocyte Hemoglobin Following Treatment of Daprodustat and rhEPO

Blood samples were collected from participants for measurement of reticulocyte hemoglobin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)

,
InterventionPicogram (pg) (Mean)
Period 1, DAY 14Period 1, DAY 28Period 2, DAY 14Period 2, DAY 28
Daprodustat0.3330.2500.8171.083
rhEPO-0.0330.717-0.350-0.117

Periods 1 and 2: Change From Baseline in Reticulocytes Following Treatment With Daprodustat and rhEPO

Blood samples were collected from participants for measurement of reticulocytes number at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)

,
Intervention10^12 cells/liter (Mean)
Period 1, DAY 14Period 1, DAY 28Period 2, DAY 14Period 2, DAY 28
Daprodustat0.0010.0040.0040.020
rhEPO0.002-0.004-0.005-0.010

Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO

Blood samples were collected for measurement of serum iron at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)

,
InterventionMicromoles per liter (umol/L) (Mean)
Period 1, DAY 14Period 1, DAY 28Period 2, DAY 14Period 2, DAY 28
Daprodustat-1.52.5-1.3-2.2
rhEPO1.73.3-3.5-3.3

Periods 1 and 2: Change From Baseline in Soluble Transferrin Receptor Following Treatment of Daprodustat and rhEPO

Blood samples were collected from participants for measurement of soluble transferrin receptor at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)

,
InterventionMilligrams per liter (mg/L) (Mean)
Period 1, DAY 14Period 1, DAY 28Period 2, DAY 14Period 2, DAY 28
Daprodustat-0.218-0.340-0.338-0.308
rhEPO0.063-0.0150.2270.195

Periods 1 and 2: Change From Baseline in Transferrin Saturation Following Treatment With Daprodustat or rhEPO

Blood samples were collected from participants for measurement of transferrin saturation at indicated time points. Transferrin saturation was measured as a percentage and is the ratio of serum iron and total iron-binding capacity multiplied by 100. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)

,
InterventionPercentage (%) of transferrin saturation (Mean)
Period 1, DAY 14Period 1, DAY 28Period 2, DAY 14Period 2, DAY 28
Daprodustat-5.23.0-5.5-6.7
rhEPO3.58.2-4.8-4.7

Periods 1 and 2: Ratio to Baseline (Day 1) in Hepcidin Following Treatment With Daprodustat and rhEPO

Blood samples were collected from participants for measurement of hepcidin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The summary of log transformed ration to baseline on markers of iron status for Hepcidin is presented here. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)

,
InterventionMicrogram per liter (ug/L) (Geometric Mean)
Period 1, DAY 14Period 1, DAY 28Period 2, DAY 14Period 2, DAY 28
Daprodustat0.8600.9160.7030.802
rhEPO0.9041.0521.2011.306

Periods 1 and 2: Ratio to Baseline in Ferritin Following Treatment With Daprodustat and rhEPO

Blood samples were collected from participants for measurement of ferritin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The summary of log transformed ration to baseline on markers of iron status for Ferritin is presented here. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)

,
InterventionMicrogram per liter (ug/L) (Geometric Mean)
Period 1, DAY 14Period 1, DAY 28Period 2, DAY 14Period 2, DAY 28
Daprodustat1.1261.1091.0671.278
rhEPO0.9371.0040.9570.911

Change From Baseline in Hemoglobin (Hgb)

(NCT00548249)
Timeframe: two time points: baseline and final evaluation (last post baseline assessment, up to 26 weeks)

Interventiongrams/ deciliter (g/dL) (Mean)
0 µg Iron/dL of Dialysate-0.177
5 µg Iron/dL of Dialysate0.258
10 µg Iron/dL of Dialysate0.462
12 µg Iron/dL of Dialysate0.173
15 µg Iron/dL of Dialysate-0.018

Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart.

(NCT00548249)
Timeframe: two separate sessions measured one week apart.

InterventionSubjects (Number)
0 µg Iron/dL of Dialysate6
5 µg Iron/dL of Dialysate6
10 µg Iron/dL of Dialysate9
12 µg Iron/dL of Dialysate7
15 µg Iron/dL of Dialysate8

Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group.

(NCT00548249)
Timeframe: At each dialysis session for up to 26 weeks

InterventionSubjects (Number)
0 µg Iron/dL of Dialysate2
5 µg Iron/dL of Dialysate1
10 µg Iron/dL of Dialysate2
12 µg Iron/dL of Dialysate0
15 µg Iron/dL of Dialysate1

Percent of Subjects Whose Hemoglobin (Hgb) Decreases by a Total of 1.0 Grams/ Deciliter (g/dL) (or More) From Baseline on Each of Two Successive Measurements.

Efficacy of a Soluble Ferric Pyrophosphate (SFP)-containing dialysate solution in maintaining physiological iron levels during chronic HD, as measured by the percent of subjects whose hgb decreases by a total of 1.0 g/dL (or more) from baseline on each of two successive measurements. Hemoglobin was obtained weekly at the mid-week dialysis treatments and compared to baseline value (average of two hgb measurements obtained at the two consecutive baseline visits prior to randomization). (NCT00548249)
Timeframe: up to 26 weeks

InterventionPercent of subjects (Number)
0 µg Iron/dL of Dialysate5
5 µg Iron/dL of Dialysate6
10 µg Iron/dL of Dialysate5
12 µg Iron/dL of Dialysate4
15 µg Iron/dL of Dialysate10

Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.

Efficacy of SFP administration in dialysate solution as measured by Chr values every four weeks, and at the end of the Subject's Treatment (up to 26 weeks). (NCT00548249)
Timeframe: Every 4 weeks

,,,,
Interventionpg (Mean)
Baseline Reticulocyte HemoglobinReticulocyte Hemoglobin/ Week 1Reticulocyte Hemoglobin/ Week 4Reticulocyte Hemoglobin/ Week 8Reticulocyte Hemoglobin/ Week 12Reticulocyte Hemoglobin/ Week 16Reticulocyte Hemoglobin/ Week 20Reticulocyte Hemoglobin/ Week 24Reticulocyte Hemoglobin/ Week 26Reticulocyte Hemoglobin/ End of TrialReticulocyte Hemoglobin/ Final Evaluation
0 µg Iron/dL of Dialysate32.5532.4232.0032.1431.8331.4531.1330.9330.7830.0631.85
10 µg Iron/dL of Dialysate32.8632.6932.6932.7532.7833.0532.8132.0832.2031.4632.19
12 µg Iron/dL of Dialysate32.3431.8731.8231.7531.8231.8630.6830.5330.7230.5531.65
15 µg Iron/dL of Dialysate32.6432.4032.0532.3532.4832.2531.6431.4030.4330.1132.13
5 µg Iron/dL of Dialysate32.9832.5832.2732.2832.1331.9531.8131.8531.3231.5031.68

Time in Days for Hgb to Decrease by a Total of > = 1.0 g/dL From Baseline on Each of Two Successive Measurements in Each Treatment Group.

Kaplan-Meier Estimate of Time to First Hgb Decrease by >= 1.0 g/dL (NCT00548249)
Timeframe: Up to 26 weeks

,,,,
InterventionDays (Number)
5th Percentile10th Percentile15th Percentile20th Percentile25th Percentile
0 µg Iron/dL of Dialysate599494115115
10 µg Iron/dL of Dialysate10106106106115
12 µg Iron/dL of Dialysate3145115115150
15 µg Iron/dL of Dialysate3131388094
5 µg Iron/dL of Dialysate24316687108

Change in Average Total Insulin Dose Per Body Weight

This measure is computed using the average amount of exogenous insulin taken per day for the 3 days prior to the visit. The average insulin use is divided by the subject's weight in kilograms (kg). The need for lower dose(s) of prescribed exogenous insulin while maintaining optimal control of a subject's diabetes reflects improved management of the underlying disease. (NCT00129259)
Timeframe: Baseline (Pre-treatment), Month 24

InterventionUnits of Insulin/kilogram/day (U/kg/day) (Mean)
Anti-CD3 mAb Plus Diabetes Standard of Care Treatment0.23
Diabetes Standard of Care Treatment0.35

Change in HbA1c

Glycosylated hemoglobin (HbA1c) is a measure of the average plasma glucose concentration over prolonged periods of time and measures the level of optimal management of underlying disease. (Normal :< 5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher).A decline in HbA1c from baseline to month 24 signifies an improvement in diabetic control. The goal of treatment: to maintain the HgA1c level as close to normal as possible without frequent occurrence of hypoglycemia. (NCT00129259)
Timeframe: Baseline (Pre-treatment), Month 24

InterventionPercentage (%) (Mean)
Anti-CD3 mAb Plus Diabetes Standard of Care Treatment0.129
Diabetes Standard of Care Treatment0.195

Change in Mean C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT)

C-peptide AUC is computed using the trapezoidal rule and dividing by the interval of time from the 4 hour Mixed Meal Tolerance Test (MMTT) where assessments are taken every 30 minutes after initial assessments 15 minutes apart. A higher C-peptide AUC is desirable as detectable C-peptide is a marker for the ability of the pancreas to produce insulin in response to a MMTT. The baseline data was used to adjust for the C-peptide AUC primary endpoint at 24 months. Missing month 24 C-peptide results are imputed using a conservative scenario. (NCT00129259)
Timeframe: Baseline (Pre-treatment), Month 24

Interventionpmol/mL (Least Squares Mean)
Anti-CD3 mAb Plus Diabetes Standard of Care Treatment-0.28
Diabetes Standard of Care Treatment-0.46

Adherence to Treatment.

Adherence to treatment was calculated as the number of days with at least one opening of the electronic device divided by the total number of monitored days. The device was a MEMS (Medication Event Monitoring System,AARDEX, Europe, Switzerland) (NCT00689793)
Timeframe: 4 weeks

Interventionpercentage of day (Mean)
Oral Treatment of Iron96
Placebo96

Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test

Subjects were asked to step on to and off a 20cm step at a rate set by a metronome. Step rate increased gradually until subject reached her submaximal predicted heart rate. (NCT00689793)
Timeframe: baseline and 4 weeks

InterventionmLO2/kg/min (Mean)
Oral Treatment of Iron40.5
Placebo40.1

Ferritin Change Before and After 4 Weeks of Treatment/Placebo

Level of ferritin measured 4 weeks after randomization (NCT00689793)
Timeframe: baseline and 4 weeks

Interventionng/mL (Mean)
Oral Treatment of Iron28.0
Placebo12.9

Hemoglobin Variation Before and After Treatment vs Placebo

The level of hemoglobin measured 4 weeks after randomization (NCT00689793)
Timeframe: baseline and 4 weeks

Interventiong/L (Mean)
Oral Treatment of Iron135
Placebo130

Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale.

"The level of fatigue perceived at baseline and after 4 weeks was scored on a 10-point visual analogue scale ranging from no fatigue=0 to very severe fatigue=10." (NCT00689793)
Timeframe: baseline and 4 weeks

Interventioncentimeter (Mean)
Oral Treatment of Iron3.4
Placebo3.5

Response of Iron Supplementation on Mental Disorder

Depression was assessed using the Prime-MD Patient Health Questionnaire (PHQ-9), self-administered by the subject.Diagnosis of depression syndrom was made scoring results of the nine item (range : 0-3). A score >15 (range of total overall scale:0-27) was considered as a depression syndrome. The outcome measure is the number the donors with a depression syndrome at baseline who had a positive response (total score= or <15) after placebo or treatment. (NCT00689793)
Timeframe: baseline and 4 weeks

Interventionparticipants (Number)
Oral Treatment of Iron3
Placebo4

Extremely Pre-term

Birth before 28 weeks gestation (NCT00860470)
Timeframe: Up to 28 weeks of gestation

Interventionparticipants (Number)
Iron and Folate136
Multiple Micronutrient106

Infant Mortality Through 6 mo of Age

Infant Mortality to Age 6 months (180 days from birth) (NCT00860470)
Timeframe: 6-months post-birth

Interventionparticipants (Number)
Iron and Folate764
Multiple Micronutrient741

Low Birth Weight

Birth weight below 2500g (NCT00860470)
Timeframe: Measured at delivery/birth

Interventionparticipants (Number)
Iron and Folate4809
Multiple Micronutrient4275

Moderate to Late Preterm

Birth between 32 and 37 weeks gestation (NCT00860470)
Timeframe: Between 31 and 38 weeks of gestation

Interventionparticipants (Number)
Iron and Folate2391
Multiple Micronutrient2113

Neonatal Mortality

Neonatal Mortality (28 days of life) (NCT00860470)
Timeframe: 1 month post-birth

Interventionparticipants (Number)
Iron and Folate625
Multiple Micronutrient626

Post-neonatal Mortality

Risk of Post-neonatal Mortality (29th -180th day of life) (NCT00860470)
Timeframe: 1-6 months post-birth

Interventionparticipants (Number)
Iron and Folate139
Multiple Micronutrient115

Preterm Birth

Being born before 37 weeks of gestation (NCT00860470)
Timeframe: Up to 37 weeks of gestation

Interventionparticipants (Number)
Iron and Folate2912
Multiple Micronutrient2510

Small for Gestation Age

Small for Gestational Age defined as birth weight <10th percentile of a standard reference (Alexander GR, Himes JH, Kaufman RB, et al. Obstet Gynecol. 1996;87(2):163-68). (NCT00860470)
Timeframe: At delivery/birth

Interventionparticipants (Number)
Iron and Folate6479
Multiple Micronutrient6405

Still Birth Rates

Stillbirth (born >=24 weeks without breathing, crying, or moving limbs). (NCT00860470)
Timeframe: 24 weeks gestation to delivery

Interventionparticipants (Number)
Iron and Folate716
Multiple Micronutrient648

Very Pre-term

Birth between 28 and 32 weeks of gestation (NCT00860470)
Timeframe: Between 27 and 33 weeks of gestation

Interventionparticipants (Number)
Iron and Folate385
Multiple Micronutrient291

Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Intervention/h (Mean)
MT-6548MT-6548+Iron supplement C
Cohort 20.13560.1629

Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Intervention/h (Mean)
MT-6548MT-6548+Iron supplement D
Cohort 30.13540.1518

Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Intervention/h (Mean)
MT-6548MT-6548+Iron supplement AMT-6548+Iron supplement B
Cohort 10.13140.13020.1647

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionug*h/mL (Mean)
MT-6548MT-6548+Iron supplement C
Cohort 2100.247.7

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionug*h/mL (Mean)
MT-6548MT-6548+Iron supplement D
Cohort 3129.316.0

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionug*h/mL (Mean)
MT-6548MT-6548+Iron supplement AMT-6548+Iron supplement B
Cohort 1105.349.237.2

Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Quantifiable Concentration (AUC0-last) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionug*h/mL (Mean)
MT-6548MT-6548+Iron supplement C
Cohort 296.346.4

Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Quantifiable Concentration (AUC0-last) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionug*h/mL (Mean)
MT-6548MT-6548+Iron supplement D
Cohort 312514.9

Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Quantifiable Concentration (AUC0-last) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionug*h/mL (Mean)
MT-6548MT-6548+Iron supplement AMT-6548+Iron supplement B
Cohort 1100.44736

Maximum Plasma Concentration (Cmax) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionug/mL (Mean)
MT-6548MT-6548+Iron supplement C
Cohort 215.59.37

Maximum Plasma Concentration (Cmax) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionug/mL (Mean)
MT-6548MT-6548+Iron supplement D
Cohort 327.12.65

Maximum Plasma Concentration (Cmax) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionug/mL (Mean)
MT-6548MT-6548+Iron supplement AMT-6548+Iron supplement B
Cohort 114.57.765.96

Mean Residence Time From Zero to Infinity (MRT0-∞) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionh (Mean)
MT-6548MT-6548+Iron supplement C
Cohort 26.975.76

Mean Residence Time From Zero to Infinity (MRT0-∞) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionh (Mean)
MT-6548MT-6548+Iron supplement D
Cohort 36.567.21

Mean Residence Time From Zero to Infinity (MRT0-∞) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionh (Mean)
MT-6548MT-6548+Iron supplement AMT-6548+Iron supplement B
Cohort 18.238.067.28

Terminal Elimination Half-life (t1/2) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionh (Mean)
MT-6548MT-6548+Iron supplement C
Cohort 25.224.4

Terminal Elimination Half-life (t1/2) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionh (Mean)
MT-6548MT-6548+Iron supplement D
Cohort 35.235.05

Terminal Elimination Half-life (t1/2) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionh (Mean)
MT-6548MT-6548+Iron supplement AMT-6548+Iron supplement B
Cohort 15.385.394.33

Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionh (Median)
MT-6548MT-6548+Iron supplement C
Cohort 21.001.00

Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionh (Median)
MT-6548MT-6548+Iron supplement D
Cohort 32.003.00

Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548

(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Interventionh (Median)
MT-6548MT-6548+Iron supplement AMT-6548+Iron supplement B
Cohort 13.003.004.00

Incidence of Diarrhea

A diarrhea episode was defined as three or more loose, liquid, or watery stools for 2 consecutive days, separated in time from an earlier or subsequent episode by at least 2 consecutive diarrhea-free days. (NCT00470158)
Timeframe: 6 months

Interventionepisodes (Number)
Combined Iron and Zinc201
Separate Iron and Zinc204
Iron Alone260
Zinc Alone224
Placebo235

Change From Baseline in Serum-phosphate Levels at the End of Treatment.

(NCT00824460)
Timeframe: 6 weeks after baseline

Interventionmmol/L (Mean)
1.25 g PA21 (250 mg Iron)-0.042
5.0 g PA21 (1,000 mg Iron)-0.348
7.5 g PA21 (1,500 mg Iron)-0.404
10.0 g PA21 (2,000 mg Iron)-0.644
12.5g PA21 (2,500 mg Iron)-0.547
Sevelamer Hydrochloride - Active Control-0.341

Change From Baseline in Serum-phosphate Levels at Week 2

(NCT00824460)
Timeframe: 2 weeks after baseline

Interventionmmol/L (Mean)
1.25 g PA21 (250 mg Iron)-0.03
5.0 g PA21 (1,000 mg Iron)-0.36
7.5 g PA21 (1,500 mg Iron)-0.41
10.0 g PA21 (2,000 mg Iron)-0.47
12.5 g PA21 (2,500 mg Iron)-0.46
Sevelamer Hydrochloride - Active Control-0.41

Change From Baseline in Serum-phosphate Levels at Week 4

(NCT00824460)
Timeframe: 4 weeks after baseline

Interventionmmol/L (Mean)
1.25 g PA21 (250 mg Iron)-0.03
5.0g PA21 (1,000 mg Iron)-0.39
7.5 g PA21 (1,500 mg Iron)-0.32
10.0 g PA21 (2,000 mg Iron)-0.58
12.5g PA21 (2,500 mg Iron)-0.53
Sevelamer Hydrochloride - Active Control-0.53

Change From Baseline in Serum-phosphate Levels at Week 5

(NCT00824460)
Timeframe: 5 weeks after baseline

Interventionmmol/L (Mean)
1.25 g PA21 (250 mg Iron)-0.05
5.0 g PA21 (1,000 mg Iron)-0.51
7.5 g PA21 (1,500 mg Iron)-0.40
10.0 g PA21 (2,000 mg Iron)-0.57
12.5 g PA21 (2,500 mg Iron)-0.58
Sevelamer Hydrochloride - Active Control-0.52

Change in 6 Minute Walk Test Results

Subjects were asked to walk for 6 minutes, unassisted. The distance walked was recorded in meters at baseline (time of randomization) and 12 weeks after baseline (time of randomization). The change from baseline to 12 weeks, related to distance, is compared and documented. (NCT01309659)
Timeframe: Baseline, 12 weeks

Interventionmeters (Mean)
Immediate Intervention Group8.05
Wait List Control-11.45

Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing

To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on Complex attention/executive processing was derived using the z-scores of the following three tests: (1) TMT Part B seconds per completed circle, (2) time score from the CogState One Back Task, and (3) accuracy score from the CogState One Back Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point (accuracy score) or by subtracting the subject's score at the time point from the overall baseline mean of the test (TMT and time score) and then dividing by the overall baseline standard deviation of the test. (NCT01309659)
Timeframe: Baseline, 12 week

Interventionchange in Z-score (Mean)
Immediate Intervention Group0.36
Wait List Control0.69

Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory

To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on Learning and memory was derived using the z-scores of the following three tests: (1) CogState ISL immediate recall score (total score from three learning trials), (2) CogState ISL immediate recall score from the first learning trial, and (3) CogState ISL delayed recall scores. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point and then dividing by the overall baseline standard deviation of the test. Higher numbers indicated a better response.There is no scale, as the results are normalized variables. (NCT01309659)
Timeframe: Baseline, 12 week

Interventionchange in Z-score (Mean)
Immediate Intervention Group0.41
Wait List Control1.39

Change in Cognitive Outcome Measures as Determined by Speed of Processing

To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on speed of processing was derived using the z-scores of the following three tests: (1) TMT Part A seconds per completed circle, (2) simple reaction time from the CogState Detection Task, and (3) choice reaction time from the CogState Identification Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the subject's score at the time point from the overall baseline mean of the test and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average. (NCT01309659)
Timeframe: Baseline, 12 Week

Interventionchange in Z-Score (Mean)
Immediate Intervention Group0.62
Wait List Control1.08

Change in Cognitive Outcome Measures as Determined by Trail Making Test Part B

To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on the Trail Making Test (TMT) Part B as measured by subjects drawing a line from 25 circled numbers to letters in 300 seconds. The change in seconds per completed circle from baseline to week 12. (NCT01309659)
Timeframe: Baseline, 12 weeks

Interventionchange in seconds per completed circle (Mean)
Immediate Intervention Group-0.77
Wait List Control-4.96

Change in Frailty Component as Determined by Grip Strength

"To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty as measured by change in grip strength. Subjects squeeze the grip strength machine 3 times with each hand. For the frailty outcome the maximum grip strength from the dominant hand is used. (change from frail at baseline to not frail at week 12). Grip strength is stratified by gender and BMI. For men with (BMI <= 24 and a grip strength (GS) <= 29) or (BMI 24.1-28 and grip strength <= 30) or (BMI >28 and a grip strength <= 32) were classified as frail. For women with (BMI <= 23 and a grip strength of <= 17) or (BMI 23.1-26 and a GS <= 17.3) or (BMI 26.1-29 and a GS <= 18) or (BMI > 29 and a GS <= 21) were classified as frail.The outcome is the number of participants who were classified as frail at baseline and changed to not frail at week 12." (NCT01309659)
Timeframe: Baseline, 12 weeks

Interventionparticipants (Number)
Immediate Intervention Group0
Wait List Control0

Change in Frailty Component as Determined by the 4 Meter Walk Speed

"To quantify the impact of anemia treatment by IV iron sucrose on change in the speed of the 4 meter walk speed. Subjects are asked to walk as fast as they can for 4 meters. Frailty was determined by the subject's speed. (change from frail at baseline to not frail at week 12). 4 m walking speed is stratified by gender and height. For men, (height of <= 173 cm and a walking speed of <= 0.65 meter/sec) or a (height > 173, <= .76 meter/sec) were classified as frail. For women, (height of <= 159 cm and a walking speed of <=.65 meter/sec) or (height >159 cm <= 0.76 meter/sec) were classified as frail.The outcome is the number of participants who were classified as frail at baseline and changed to not frail at week 12." (NCT01309659)
Timeframe: Baseline, 12 weeks

Interventionparticipants (Number)
Immediate Intervention Group0
Wait List Control0

Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score

To quantify the impact of anemia treatment by IV iron sucrose on self -reported outcomes measures by subjects answering 47 questions for patients with anemia and or fatigue. This test detects self-report functional changes and QoL. Change from baseline to 12 weeks. Scores range from 0-188 with higher scores indicating better function. (NCT01309659)
Timeframe: Baseline, 12 weeks

Interventionchange in the total score (Mean)
Immediate Intervention Group10.6
Wait List Control0.0

Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS)

To quantify the impact of anemia treatment by IV iron sucrose on self-reported outcomes measures by change in SF36 physical component score. The SF-36 form identifies self-report physical function and global measure of quality of life and is a multi-purpose, short-form health survey consisting of 36 questions. The Physical Component Summary (PCS) is a subscale of the SF-36 that correlates with physical health domains of the SF-36 ( Physical Function, Role-Physical, and Bodily Pain). The change is calculated and compared from baseline to week 12. The SF-36 PCS score is a norm based sore with a mean of 50 and standard deviation of 10 where results above and below 50 are above and below the average, respectively, in the 2009 general US population. (NCT01309659)
Timeframe: Baseline, 12 weeks

Interventiont score (Mean)
Immediate Intervention Group-1.89
Wait List Control-3.17

Change in the Frailty Component as Determined by Self-reported Activity Level

"To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty as measured by change in self-reported activity level. Frailty for activity level is classified by subjects responses to 6physical activity questions on the short version of the Minnesota Leisure Time Activity Questionnaire , were related to walking for exercise, moderately strenuous outdoor chores, dancing, bowling, and regular exercise. The Women's Health And Aging Study (WHAS) scoring algorithm was used to define frailty for self-reported activity level. The answers to these questions were used to calculate kilocalories (Kcals) per week, using the WHAS algorithm, which is further satisfied by by gender. For men, Kcals < 128 per week is frail. For women, Kcals < 90 per week is frail. This is a categorical measurement of yes or no. The outcome is the number of participants who were classified as frail at baseline and changed to not frail at week 12." (NCT01309659)
Timeframe: Baseline, 12 week

Interventionparticipants (Number)
Immediate Intervention Group0
Wait List Control0

Correlation Between Baseline Soluble Transferrin Receptor and the Change in HB From Baseline to 12 Weeks

Correlation between baseline soluble transferrin receptor and the change in hemoglobin from the baseline to 12 weeks. (NCT01309659)
Timeframe: baseline, 12 weeks

Interventioncorrelation coefficient (Number)
Immediate Intervention Group-0.192
Wait List Control-0.886

Correlation Between Baseline Soluble Transferrin Receptor and the Change in the 6 Meter Walk Test Distance

Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance from baseline to 12 weeks (NCT01309659)
Timeframe: baseline, 12 weeks

Interventioncorrelation coefficient (Number)
Immediate Intervention Group0.192
Wait List Control0.349

Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in Hemoglobin

Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin from baseline to 12 weeks. (NCT01309659)
Timeframe: baseline, 12 weeks

Interventioncorrelation coefficient (Number)
Immediate Intervention Group-0.500
Wait List Control-0.714

Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in the 6 Minute Walk Test Distance

Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance from baseline to 12 weeks (NCT01309659)
Timeframe: baseline, 12 weeks

Interventioncorrelation coefficient (Number)
Immediate Intervention Group-0.300
Wait List Control0.486

Number of Participants Who Had a Hemoglobin Increase >= 1g/dL

To assess the efficacy of IV iron sucrose in improving Hemoglobin by at least 1 g/dL; an increase from baseline to week 12. (NCT01309659)
Timeframe: baseline, 12 weeks

Interventionparticipants (Number)
Immediate Intervention Group1
Wait List Control0

Change in Frailty Component Related to Fatigue/ Exhaustion

"Subjective fatigue/exhaustion: If any of the following three criteria are met, the patient will be classified as frail for fatigue/exhaustion:~In the past month, on average, have you been feeling unusually tired during the day? is answered yes and indicated as all of the time or most of the time.~In the past month, on average, have you felt unusually weak? is answered yes and indicated as all of the time or most of the time.~Energy level on a scale of 0 (no energy) to 10 (most energy) reported as ≤ 3. If the subject answers YES to any of the above noted 3 questions, then they are classified as FRAIL.~The change in frailty for fatigue/ exhaustion is defined as changing from frail at baseline to not frail at week 12 as reported by the subject." (NCT01309659)
Timeframe: baseline, 12 weeks

,
Interventionparticipants (Number)
Frailty change - self reported exhaustionFrailty change - self-reported low energy
Immediate Intervention Group90
Wait List Control100

Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance

Correlation between baseline serum ferritin, serum iron, and transferrin saturation and the change in 6 Minute Walk Test distance from baseline to 12 weeks. (NCT01309659)
Timeframe: baseline, 12 weeks

,
Interventioncorrelation coefficient (Number)
Correlation for ferritinCorrelation for ironCorrelation TSAT
Immediate Intervention Group0.6170.3320.400
Wait List Control0.100-0.133-0.350

Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB)

Correlation between baseline serum ferritin, serum iron, and transferrin saturation and the change in HB from baseline to 12 weeks. (NCT01309659)
Timeframe: baseline, 12 weeks

,
Interventioncorrelation coefficient (Number)
Correlation btw baseline ferritin & change in HgbCorrelation btw baseline iron & change in HgbCorrelation btw baseline TST & change in Hgb
Immediate Intervention Group0.3830.3230.200
Wait List Control0.1890.5410.584

Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA)

For infants discharged home prior to 36 wks PMA, the last Hct was used.For infants transferred prior to 36 wks PMA, the Hct at receiving hospital was used if available. A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and those transfused could be included in an intention-to-treat analysis.Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wk PMA Hct was used as the primary outcome. (NCT01125163)
Timeframe: at 36 weeks adjusted postmenstrual age

Intervention% Hematocrit (Mean)
Multivitamin With Iron29.2
Multivitamin Without Iron28.2

Number of Participants Who Received Red Cell Transfusions During Intervention Period

The numbers below represent the number of participants in each arm that received a transfusion during intervention period. (NCT01125163)
Timeframe: from study day 1 to 36 week adjusted postmenstrual age or discharge if the infant is discharged sooner

Interventionparticipants (Number)
Multivitamin With Iron48
Multivitamin Without Iron54

Haemoglobin Level

Haemoglobin level (g/L) measured by cyanmethaemoglobin method (NCT01198574)
Timeframe: at week 0, week 6 and week12

,,,
Interventiong/L (Mean)
Hb week 0 (Baseline)Hb week 6 (Midline)Hb week 12 (Endline)
Iron and Vitamin A Group88.499.2111.4
Iron Group88.398.1110.8
Placebo Group89.698.3109.7
Vitamin A Group89.298.7109.0

Status of Cellular Iron Deficiency

Cellular Iron deficiency status is also measured by serum transferrin receptor (NCT01198574)
Timeframe: at week 0, week 6 and week12

,,,
Interventionmg/L (Geometric Mean)
serum transferrin receptor (Baseline)serum transferrin receptor (Midline)serum transferrin receptor (Endline)
Iron and Vitamin A Group7.166.736.24
Iron Group7.096.696.44
Placebo Group6.746.596.61
Vitamin A Group6.566.396.27

Status of Tissue Iron Store

Tissue iron store was measured by serum ferritin (NCT01198574)
Timeframe: at week 0, week 6 and week12

,,,
Interventionµg/L (Geometric Mean)
serum ferritin (Baseline)serum ferritin (Midline)serum ferritin (Endline)
Iron and Vitamin A Group25.932.335.4
Iron Group32.134.539.6
Placebo Group31.126.528.2
Vitamin A Group34.432.135.0

Highest Change From Baseline in Ferritin (ng/mL) up to Day 56

(NCT00236977)
Timeframe: Change from Baseline up to Day 56

Interventionng/mL (Mean)
Venofer391.7
Ferrous Sulfate45

Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56

(NCT00236977)
Timeframe: Change from Baseline up to Day 56

Interventiong/dL (Mean)
Venofer1.1
Ferrous Sulfate.8

Mean Change From Baseline in Hemoglobin (g/dL) at Day 56

(NCT00236977)
Timeframe: Change from Baseline at Day 56

Interventiong/dL (Mean)
Venofer.7
Ferrous Sulfate.3

Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56

(NCT00236977)
Timeframe: Change from Baseline at Day 56

Interventionpercentage of change (Mean)
Venofer8.5
Ferrous Sulfate5.5

Mean Change in Ferritin (ng/mL) From Baseline to Day 56

(NCT00236977)
Timeframe: Change from Baseline at Day 56

Interventionng/mL (Mean)
Venofer230
Ferrous Sulfate30

Number of Subjects With a Clinical Response

Clinical Response (change in Hemoblobin (Hgb) >= 1gm/dL and change in ferritin >= 160ng/ml) (NCT00236977)
Timeframe: Change from Baseline up to Day 56

Interventionparticipants (Number)
Venofer31
Ferrous Sulfate1

Patients With an Increase in Hemoglobin >= 1gm/dL.

(NCT00236977)
Timeframe: Change from Baseline up to Day 56

Interventionparticipants (Number)
Venofer35
Ferrous Sulfate23

Candida Culture Free After Maintenance Therapy

candida culture free (monthly vaginal cultures were obtained) (NCT00895453)
Timeframe: 12 months

Interventionparticipants (Number)
Itraconazole18
Itraconazole + Lactobacillus Gasseri19
Classic Homeopathy9

Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline)

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. (NCT01414075)
Timeframe: Baseline up to Week 13

Interventionweeks (Median)
Arm A + E (Participants on HD): Roxadustat Only, No Iron4.0
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg4.0
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg4.0
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg4.0

Number of Participants Requiring Therapeutic Phlebotomy

Number of participants who required therapeutic phlebotomy due to TEAE of abnormal erythropoiesis is reported. (NCT01414075)
Timeframe: Baseline up to Week 13

InterventionParticipants (Count of Participants)
Arm A + E (Participants on HD): Roxadustat Only, No Iron0
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg1
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg0
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg0

Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. (NCT01414075)
Timeframe: Week 3 to 13

InterventionParticipants (Count of Participants)
Arm A + E (Participants on HD): Roxadustat Only, No Iron17
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg10
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg8
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg10

Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. (NCT01414075)
Timeframe: Week 3 to 13

InterventionParticipants (Count of Participants)
Arm A + E (Participants on HD): Roxadustat Only, No Iron10
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg8
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg8
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg9

Number of Participants With Mean Hb Values Within 10.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥10.0 g/dL and Change of Hb ≥1 g/dL

(NCT01414075)
Timeframe: Weeks 10-13

InterventionParticipants (Count of Participants)
Arm A + E (Participants on HD): Roxadustat Only, No Iron15
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg7
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg7
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg9

Number of Participants With Mean Hb Values Within 11.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥11.0 g/dL and Change of Hb ≥1 g/dL

(NCT01414075)
Timeframe: Weeks 10-13

InterventionParticipants (Count of Participants)
Arm A + E (Participants on HD): Roxadustat Only, No Iron5
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg2
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg5
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg7

Number of Participants With TEAEs

An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs were defined as any event that either began or worsened after the first administration of study drug and within 28 days of the last dose. A summary of other nonserious AEs and all serious AEs, regardless of causality is located in Reported AE section. (NCT01414075)
Timeframe: Baseline up to Week 16

InterventionParticipants (Count of Participants)
Arm A + E (Participants on HD): Roxadustat Only, No Iron16
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg6
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg3
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg5

Number of Participants Withdrawn From the Study Due to Inadequate Efficacy

Number of participants withdrawn from the study due to inadequate efficacy is reported. (NCT01414075)
Timeframe: Baseline up to Week 16

InterventionParticipants (Count of Participants)
Arm A + E (Participants on HD): Roxadustat Only, No Iron0
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg0
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg0
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg0

Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline)

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. (NCT01414075)
Timeframe: Baseline up to Week 13

Interventionmg/kg (Mean)
Arm A + E (Participants on HD): Roxadustat Only, No Iron4.2
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg4.2
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg4.5
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg4.3

Change From Baseline in Ferritin at Week 13

Baseline was defined as the average of the last 2 values prior to the first dose administration. (NCT01414075)
Timeframe: Baseline, Week 13

,,,
Interventionmicrograms/liter (µg/L) (Mean)
BaselineChange at Week 13
Arm A + E (Participants on HD): Roxadustat Only, No Iron156.4-119.7
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg162.5-51.1
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg182.0-25.2
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg137.4-65.1

Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13

FACT-An is composed of 27 core items which assess participant's function in 4 domains and 20 anemia-related items, grouped into 5 subscales as follows: Physical well-being (PWB): 7 items; Social/family well-being (SWB): 7 items; Emotional well-being (EWB): 6 items; Functional well-being (FWB): 7 items; and Anemia: 20 items. All FACT-An items were rated as: 0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much. Each subscale score was the sum of scores for the items in the subscale. The FACT-An total score was the sum of all 5 subscale scores, ranging from 0 (worst) - 188 (best). Higher scores represented better quality of life. Baseline is defined as the last non-missing value prior to the first dose administration. (NCT01414075)
Timeframe: Baseline, Weeks 9 and 13

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 9Change at Week 13
Arm A + E (Participants on HD): Roxadustat Only, No Iron123.58.27.3
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg118.94.05.9
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg128.81.95.1
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg122.812.812.9

Change From Baseline in Reticulocyte Hemoglobin Content at Week 13

(NCT01414075)
Timeframe: Baseline, Week 13

,,,
Interventionpicogram (pg) (Mean)
BaselineChange at Week 13
Arm A + E (Participants on HD): Roxadustat Only, No Iron31.0-2.2
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg31.6-1.9
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg31.5-1.0
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg30.4-0.2

Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13

The SF-36 V2 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The physical functioning subscore and vitality subscore are reported. The scores ranged from 0 (worst) to 100 (Best). Higher score indicated a better health state. Baseline is defined as the last non-missing value prior to the first dose administration. (NCT01414075)
Timeframe: Baseline, Weeks 9 and 13

,,,
Interventionunits on a scale (Mean)
Physical functioning subscore: BaselinePhysical functioning subscore: Change at Week 9Physical functioning subscore: Change at Week 13Vitality subscore: BaselineVitality subscore: Change at Week 9Vitality subscore: Change at Week 13
Arm A + E (Participants on HD): Roxadustat Only, No Iron38.84.85.246.32.93.9
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg40.71.61.848.2-1.01.6
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg41.21.54.849.03.43.1
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg40.83.42.346.85.96.2

Change From Baseline in Transferrin Saturation (TSAT) at Week 13

(NCT01414075)
Timeframe: Baseline, Week 13

,,,
Interventionpercentage of transferrin (Mean)
BaselineChange at Week 13
Arm A + E (Participants on HD): Roxadustat Only, No Iron18.8-7.4
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg19.02.6
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg18.10.7
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg19.3-1.6

Maximum Change From Baseline in Hb During Weeks 3-13

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. This outcome measure is derived from the maximum change from baseline during Weeks 3-13, without last observation carried forward (LOCF) imputation. (NCT01414075)
Timeframe: Baseline, Weeks 3-13

,,,
Interventiongrams/deciliter (g/dL) (Mean)
BaselineChange at Weeks 3-13
Arm A + E (Participants on HD): Roxadustat Only, No Iron8.12.8
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg8.53.5
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg8.43.5
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg8.73.3

Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. (NCT01414075)
Timeframe: Baseline, Weeks 2-5, 6-9, and 10-13

,,,
Interventiong/dL (Mean)
BaselineChange at Weeks 2-5Change at Weeks 6-9Change at Weeks 10-13
Arm A + E (Participants on HD): Roxadustat Only, No Iron8.11.12.02.1
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg8.51.12.32.7
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg8.41.02.03.0
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg8.70.81.82.4

Number of Participants Requiring Dose Increase at Weeks 5 and 9

Number of participants requiring dose increase due to any reasons is reported. (NCT01414075)
Timeframe: Weeks 5 and 9

,,,
InterventionParticipants (Count of Participants)
Week 5Week 9
Arm A + E (Participants on HD): Roxadustat Only, No Iron28
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg35
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg23
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg45

Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis

Number of participants requiring dose reduction or dose discontinuation due to excessive erythropoiesis is reported. (NCT01414075)
Timeframe: Weeks 5 and 9

,,,
InterventionParticipants (Count of Participants)
Dose reduced at Week 5Dose interrupted at Week 5Dose reduced at Week 9Dose interrupted at Week 9
Arm A + E (Participants on HD): Roxadustat Only, No Iron3111
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg5000
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg3030
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg5001

Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C)

Number of participants requiring rescue treatment with an ESA, RBC transfusion, or IV Iron (Excluding Arm C) was reported. (NCT01414075)
Timeframe: Baseline up to Week 13

InterventionParticipants (Count of Participants)
Blood transfusion for severe anemiaBlood transfusion for gastrointestinal bleeding
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg10

Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C)

Number of participants requiring rescue treatment with an ESA, RBC transfusion, or IV Iron (Excluding Arm C) was reported. (NCT01414075)
Timeframe: Baseline up to Week 13

,,
InterventionParticipants (Count of Participants)
Blood transfusion for severe anemiaBlood transfusion for gastrointestinal bleedingIV iron for acute iron deficiencyIV iron for a treatment-emergent adverse event (TEAE) of thrombocytosis
Arm A + E (Participants on HD): Roxadustat Only, No Iron0111
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg0000
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg0000

Number of Participants Who Achieved Maximum Hb During Weeks 3-13

(NCT01414075)
Timeframe: Weeks 3-13

,,,
InterventionParticipants (Count of Participants)
<10 g/dL10 to <11 g/dL11 to 13 g/dL>13 to 14 g/dL>14 g/dL
Arm A + E (Participants on HD): Roxadustat Only, No Iron671000
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg13512
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg20530
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg01900

Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. (NCT01414075)
Timeframe: Weeks 5, 9, and 13

,,,
InterventionParticipants (Count of Participants)
Week 5Week 9Week 13
Arm A + E (Participants on HD): Roxadustat Only, No Iron212222
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg91011
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg7910
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg7910

Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. The number of participants who fall within the following categories of maximum change are reported: <1 g/dL, ≥1 g/dL, 1 to <2 g/dL, 2 to <3 g/dL, >3 to <4 g/dL, ≥4 g/dL. (NCT01414075)
Timeframe: Baseline, Weeks 3-13

,,,
InterventionParticipants (Count of Participants)
<1 g/dL≥1 g/dL1 to <2 g/dL2 to <3 g/dL>3 to <4 g/dL≥4 g/dL
Arm A + E (Participants on HD): Roxadustat Only, No Iron1224972
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg1112225
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg0102044
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg0100532

Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13

(NCT01414075)
Timeframe: Weeks 6-9 and 10-13

,,,
InterventionParticipants (Count of Participants)
Week 6-9Week 10-13
Arm A + E (Participants on HD): Roxadustat Only, No Iron108
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg43
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg22
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg31

Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13

(NCT01414075)
Timeframe: Weeks 6-9 and 10-13

,,,
InterventionParticipants (Count of Participants)
Weeks 6-9Weeks 10-13
Arm A + E (Participants on HD): Roxadustat Only, No Iron65
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg52
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg45
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg57

Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13

(NCT01414075)
Timeframe: Weeks 6-9 and 10-13

,,,
InterventionParticipants (Count of Participants)
Week 6-9Week 10-13
Arm A + E (Participants on HD): Roxadustat Only, No Iron00
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg01
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg01
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg00

Number of Participants With Potentially Clinically Significant Laboratory Tests

Criteria for the potential clinical significance included: bilirubin (µmol/L) >1.5 * upper limit of normal (ULN), potassium (mmol/L) >1.2 * ULN, neutrophils (*10^9/L) ≤1, protein (g/L) >1.1 * ULN, leukocytes (*10^9/L) ≤2.5 or ≥15. (NCT01414075)
Timeframe: Baseline up to Week 16

,,,
InterventionParticipants (Count of Participants)
BilirubinPotassiumNeutrophilsProteinLeukocytes
Arm A + E (Participants on HD): Roxadustat Only, No Iron12011
Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg01100
Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg00101
Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg01000

Hemoglobin Concentration Over Time

The primary outcome will be the change in the peripheral blood hemoglobin concentration in grams/deciliter upon serial measurements at 0, 4, 8, and 12 weeks post-initiation of treatment. The primary analysis consists of a linear mixed regression model, which incorporates all subsequent time points into the model and includes treatment and time as covariates and patient random effects to account for correlation among longitudinal measurements from the same patients. (NCT01904864)
Timeframe: 12 weeks

,
Interventiong/dL (Mean)
Baseline4 Weeks8 Weeks12 Weeks
Ferrous Sulfate7.910.411.411.9
NovaFerrum® (Iron Polysaccharide Complex)7.79.310.511.1

Change From Baseline in the Restless Legs Syndrome Rating Scale

Change in International Restless Legs Severity Scale (IRLS) score reflecting RLS severity on the scale of 0-40. The higher the negative score the better the outcome (NCT02499354)
Timeframe: Baseline and at 6 weeks after treatment

Interventionunits on a scale (Mean)
Oral Iron-14.0000
IV Iron-9.7353

Number of Participants With Adverse Events Judged Related or Possibly Related to Treatment.

Patient reported gastrointestinal or constitutional adverse events (NCT02499354)
Timeframe: Up to six weeks

InterventionParticipants (Count of Participants)
Oral Iron22
IV Iron11

Percentage of Participants With Improvement on Clinical Global Impression Scale

Seven questions ranging from Very Much Improved to Very Much Worse: Participant had to be at least Very Much Improved to be considered as having improved. The CGI scale consisted of one question. (NCT02499354)
Timeframe: Six weeks

Interventionpercentage of participants (Number)
Oral Iron75
IV Iron68

Change in Serum Phosphorus Levels From Baseline to Week 12

Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group. (NCT01324128)
Timeframe: Week 12 post Baseline

Interventionmg/dL (Least Squares Mean)
PA21 (2.5 g Tablet) Stage 1-2.19
Sevelamer Carbonate Stage 1-2.45

Change in Serum Phosphorus Levels From Week 24 to Week 27

Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27 (NCT01324128)
Timeframe: Week 24, Week 27

Interventionmg/dL (Least Squares Mean)
PA21 (MD) Stage 20.25
PA21-1 (LD) Stage 21.92

Hemoglobin

Serum hemoglobin level (NCT01975272)
Timeframe: 3 weeks postoperative

Interventionmmol/L (Mean)
Ferinject8.4
Ferrous Fumarate7.9
Placebo Infusion and Tablets7.1

Serum Ferritin

Serum levels of ferritin (NCT01975272)
Timeframe: 3 weeks postoperative

Interventionmicrogram/L (Mean)
Ferinject422
Ferrous Fumarate57
Placebo Infusion and Tablets37

Serum Hepcidin

Serum hepcidin level (NCT01975272)
Timeframe: 3 weeks postoperative

Interventionnmol/L (Mean)
Ferinject11.6
Ferrous Fumarate2.2
Placebo Infusion and Tablets1.7

Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit)

Percent change in total fibroid volume from screening to end of treatment visit (Week 13 visit) assessed by MRI and read centrally by a radiologist who was unaware of the study-group assignments. The total fibroid volume was the sum of the individual fibroid volumes. (NCT00755755)
Timeframe: Week 13

Interventionpercentage of change (Median)
A (PGL4001 5mg)-21.2
B (PGL4001 10mg)-12.3
C (Placebo)3

Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13)

"Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.~Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.~A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.~Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.~The week 13 PBAC score was calculated using the last 28 days of treatment." (NCT00755755)
Timeframe: Week 13 visit

Interventionpercentage of patients (Number)
A (PGL4001 5mg)91.5
B (PGL4001 10mg)92.5
C (Placebo)18.8

Percent Transferrin Saturation

(NCT02038023)
Timeframe: 4 weeks post infusion or post-partum

Interventionpercent saturation (Fe/TIBC) (Mean)
Iron Deficient Gravidas22.64

Safety as Measured by Number of Adverse Events

To evaluate the safety of IV low molecular weight iron dextran in pregnant women. Also to asses maternal and fetal outcomes-preterm delivery, low-birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups. A questionaire with a list of symptoms to include nausea, dizziness, hypotension, edema, headache, abdominal pain, chest pain, cough, itching, fever, back pain, muscle cramps and rash are asked immediately after administration and phone calls at 24, 48 hours and 7 days. (NCT02038023)
Timeframe: 4 weeks after infusion and 4 weeks post-partum

Interventionminor adverse events (Number)
Only One Group[6

Serum Ferritin

(NCT02038023)
Timeframe: 4 weeks post infusion or post-partum

Interventionng/mL (Mean)
Intravenous Iron126.29

Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD).

(NCT02038023)
Timeframe: 4 weeks after infusion or post-partum

InterventionParticipants (Count of Participants)
Improvement of > or equal to 1 g/dLImprovement of > or equal to 2 g/dL
Iron Deficient Gravidas3511

Number of Subjects Achieving Clinical Success

Summary of the Number of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and Stable EPO Dosing (±25% of Baseline Dose) (NCT00239642)
Timeframe: anytime during the 12 week post-baseline period

Interventionparticipants (Number)
Venofer (0.5 mg/kg)44
Venofer (1.0 mg/kg)40
Venofer (2.0 mg/kg)33

Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive

Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive (NCT00239642)
Timeframe: anytime during the 12-week post-baseline period

Interventionparticipants (Number)
Venofer (0.5 mg/kg)46
Venofer (1.0 mg/kg)43
Venofer (2.0 mg/kg)38

Percentage (%) of Subjects Achieving Clinical Success

Summary of the Percentage (%) of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and stable EPO Dosing (±25% of Baseline Dose) (NCT00239642)
Timeframe: anytime during the 12 week post-baseline period

Interventionpercentage of subjects (Number)
Venofer (0.5 mg/kg)95.7
Venofer (1.0 mg/kg)88.9
Venofer (2.0 mg/kg)82.5

Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive

Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive (NCT00239642)
Timeframe: anytime during the 12 week post-baseline period

Interventionpercentage of subjects (Number)
Venofer (0.5 mg/kg)100.0
Venofer (1.0 mg/kg)95.6
Venofer (2.0 mg/kg)95.0

Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline

Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease >25% in EPO Dose from Baseline (NCT00239642)
Timeframe: anytime during the 12 week post-baseline period

Interventionpercentage of subjects (Number)
Venofer (0.5 mg/kg)100.0
Venofer (1.0 mg/kg)100.0
Venofer (2.0 mg/kg)97.5

Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive

Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive (NCT00239642)
Timeframe: anytime during the 12 week post-baseline period

Interventionpercentage of subjects (Number)
Venofer (0.5 mg/kg)95.7
Venofer (1.0 mg/kg)93.3
Venofer (2.0 mg/kg)92.5

Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline

Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease >25% in EPO dose from Baseline (NCT00239642)
Timeframe: anytime during the 12 week post-baseline period

Interventionparticipants (Number)
Venofer (0.5 mg/kg)46
Venofer (1.0 mg/kg)45
Venofer (2.0 mg/kg)39

Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive

Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive (NCT00239642)
Timeframe: anytime during the 12 week post-baseline period

Interventionparticipants (Number)
Venofer (0.5 mg/kg)44
Venofer (1.0 mg/kg)42
Venofer (2.0 mg/kg)37

Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event

Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm (NCT00239642)
Timeframe: baseline through week 12

Interventionparticipants (Number)
Venofer (0.5 mg/kg)27
Venofer (1.0 mg/kg)25
Venofer (2.0 mg/kg)26

Hemoglobin Levels at 12-weeks. Marginal Means (95% CI).

Marginal means (95% CI) at 12-weeks using a generalized mixed-effects model with adjustments for baseline values and village clusters. Multiple imputation was used to impute n=49 missing values for hemoglobin at endline. (NCT02481375)
Timeframe: 12-weeks of intervention

Interventiong/L (Mean)
Multiple Micronutrients With Iron123
Multiple Micronutrients Without Iron116
Iron Only121
Placebo116

Change in Calcium x Phosphate Product From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)

Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in Calcium x Phosphate Product . An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Day 29 (Visit 11), which were to include the fixed, categorical effects of treatment, as well as the continuous, fixed covariates of Baseline concentrations for Calcium x Phosphate Product. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. In CKD subjects (Stages 3-5), the clinical recommendation (KDOQI) is that serum calcium x phosphate product should be maintained at < 55 mg^2/dL^2 (4.4 mmol^2 /L^2). (NCT02151643)
Timeframe: Day 1 to Day 29

Interventionmg^2/dL^2 (Mean)
Group 1 - PT20 400 mg Tid-5.515
Group 2 - PT20 800 mg Tid-4.035
Group 3 - PT20 1600 mg Tid-11.127
Group 4 - PT20 3200 mg Tid-10.996
Group 5 - Placebo Tid-0.778

Change in Gastrointestinal Symptom Rating System (GSRS) Overall Score From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)

The GSRS assesses the impact of treatment-related GI complications. It includes 15 items divided into 5 subscales (diarrhoea, indigestion, abdominal pain, constipation, and reflux), and uses a seven-grade Likert scale to assess symptoms (1 = no discomfort at all, 7 = very severe discomfort). The total score was calculated as the average score of all 15 items. If data were missing from one or more subscales, the mean of the completed items within the subscale was to be used for the subscale score, provided that more than half of the subscale items were complete. If more than half of the items within a subscale were missing, the subscale score and overall score were also to be defined as missing. The change in overall GSRS score from Baseline (Visit 7, Day 1) to Visit 11 (Day 29) was summarised by treatment and a two-sample t-test was to be used to identify differences between the placebo and PT20 dose groups. The higher the score, the more severe the gastrointestinal symptoms. (NCT02151643)
Timeframe: Day 1 to Day 29

Interventionscore on a scale (Mean)
Group 1 - PT20 400 mg Tid-0.9
Group 2 - PT20 800 mg Tid2.8
Group 3 - PT20 1600 mg Tid0.4
Group 4 - PT20 3200 mg Tid1.6
Group 5 - Placebo Tid0.1

Change in Haemoglobin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)

Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in haemoglobin concentration. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Visit 11 (Day 29), which were to include the fixed, categorical effects of treatment as well as the continuous, fixed covariates of Baseline concentrations for haemoglobin. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. (NCT02151643)
Timeframe: Day 1 to Day 29

Interventiong/dL (Mean)
Group 1 - PT20 400 mg Tid0.02
Group 2 - PT20 800 mg Tid-0.25
Group 3 - PT20 1600 mg Tid-0.22
Group 4 - PT20 3200 mg Tid0.18
Group 5 - Placebo Tid-0.13

Change in Serum Ferritin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)

Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in serum ferritin concentration. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Visit 11 (Day 29), which were to include the fixed, categorical effects of treatment and week (Visit), as well as the continuous, fixed covariates of Baseline concentrations for serum ferritin. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. (NCT02151643)
Timeframe: Day 1 to Day 29

Interventionng/mL (Mean)
Group 1 - PT20 400 mg Tid50
Group 2 - PT20 800 mg Tid48.8
Group 3 - PT20 1600 mg Tid10.1
Group 4 - PT20 3200 mg Tid69.9
Group 5 - Placebo Tid-67.0

Change in Serum Phosphate Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)

The primary efficacy endpoint was the change in serum phosphate concentration from Baseline (Visit 7, Day 1) to Visit 11 (Day 29). All study specific blood samples were collected, processed and analysed using a central laboratory. (NCT02151643)
Timeframe: Day 1 to Day 29

Interventionmg/dL (Mean)
Group 1 - PT20 400 mg Tid-0.4
Group 2 - PT20 800 mg Tid-0.59
Group 3 - PT20 1600 mg Tid-1.29
Group 4 - PT20 3200 mg Tid-1.363
Group 5 - Placebo Tid-0.165

Change in Transferrin Saturation From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)

Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in transferrin saturation. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Day 29 (Visit 11), which were to include the fixed, categorical effects of treatment and week, as well as the continuous, fixed covariates of Baseline concentrations for transferrin saturation. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. (NCT02151643)
Timeframe: Day 1 to Day 29

Interventionpercent (Mean)
Group 1 - PT20 400 mg Tid2.20
Group 2 - PT20 800 mg Tid0.40
Group 3 - PT20 1600 mg Tid5.84
Group 4 - PT20 3200 mg Tid-4.59
Group 5 - Placebo Tid-0.45

Change in Hb Concentration

(NCT01145638)
Timeframe: Baseline week 4

Interventiong/dL (Mean)
Iron Isomaltoside 10000.48
Iron Sulphate0.44

Change in Hemoglobin From Baseline to Week 24

(NCT01145638)
Timeframe: 24 weeks

Interventiong/dL (Mean)
Iron Isomaltoside 10001.60
Iron Sulphate1.78

Number of Subjects With an Haemoglobin (Hb) Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5

"The primary efficacy endpoint of the trial was the count of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5. 'Any time' implied that if the endpoint was met at a time-point prior to or at week 5, the effect (increase of ≥ 2 g/dL) did not have to be maintained throughout the trial in order for a subject to be a responder.~Number of responders (i.e. a subject with increase in Hb ≥ 2 g/dL from baseline at any time from week 1 to week 5) and percentages according to number of subjects in the analysis set were summarised." (NCT02130063)
Timeframe: From baseline to week 5

Interventionparticipants (Number)
Iron Isomaltoside 1000 (Monofer®)226
Iron Sucrose (Venofer®)83

Change in Hb Concentration

(NCT02130063)
Timeframe: From baseline to week 2, 4 and 5

,
Interventiong/dL (Mean)
Week 2Week 4Week 5
Iron Isomaltoside 1000 (Monofer®)1.562.352.52
Iron Sucrose (Venofer®)0.871.742.05

Change in Serum (s)-Ferritin Concentration

(NCT02130063)
Timeframe: From baseline to week 1, 2, 4, and 5

,
Interventionng/mL (Mean)
Week 1Week 2Week 4Week 5
Iron Isomaltoside 1000 (Monofer®)431.2516.6285.3241.2
Iron Sucrose (Venofer®)86.9126.2195.0185.7

Change in Transferrin Saturation (TSAT)

(NCT02130063)
Timeframe: From baseline to week 1, 2, 4, and 5

,
Interventionpercent (Mean)
Week 1Week 2Week 4Week 5
Iron Isomaltoside 1000 (Monofer®)15.717.916.315.6
Iron Sucrose (Venofer®)3.35.711.511.8

Ferritin

Comparison of Ferritin at 6 months between the 2 Groups (NCT00318812)
Timeframe: 6 months

Interventionug/L (Median)
Heme Iron85.5
Iron Sucrose244

Hemoglobin Concentration at 6 Months

(NCT00318812)
Timeframe: 6 months

Interventiong/L (Median)
Heme Iron117
Iron Sucrose113

Transferrin Saturation

Comparison of Transferrin Saturation between the Groups (NCT00318812)
Timeframe: 6 Months

Interventionpercentage of bound iron sites (Median)
Heme Iron21.5
Iron Sucrose21.5

Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale

Validated rating scale of RLS symptoms (Range 1 [mild] - 40 [severe]) (NCT00895232)
Timeframe: Baseline to Day 84

Interventionunits on a scale (Mean)
Cohort I (Venofer 500mg x 1 Dose)-2.4
Cohort II (Venofer 500mg X 2 Doses)-14.3
Cohort III (Venofer 500mg x 2 Doses)-16.0

Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's)

Quantifies amount of leg movement (NCT00895232)
Timeframe: Baseline to Day 84

InterventionPLM's per hour (Mean)
Cohort I (Venofer 500mg x 1 Dose)-7.2
Cohort II (Venofer 500mg X 2 Doses)-75.0
Cohort III (Venofer 500mg x 2 Doses)-96.2

Percentage (%) of Subjects Responding to Treatment From Baseline to Day 84 Based on Global Assessments by the Examiner.

Response is defined as any effect based on a scale of 0 through 4 where 0 = no effect, 1 = mild effect, 2 = moderate effect, 3 = marked effect, and 4 = dramatic effect. (NCT00895232)
Timeframe: Baseline to Day 84

Interventionpercent of participants (Number)
Cohort I (Venofer 500mg x 1 Dose)28.6
Cohort II (Venofer 500mg X 2 Doses)66.7
Cohort III (Venofer 500mg x 2 Doses)66.7

Change From Baseline in O2 Uptake Kinetics as Assessed by Mean Response Time From CPET

To determine the impact of oral Fe repletion on O2 Uptake Kinetics as measured by CPET (NCT02188784)
Timeframe: Measured at BL week 16

Interventionseconds (Mean)
Polysaccharide Iron Complex 150 mg2.63
Placebo (for Polysaccharide Iron Complex 150 mg)-0.95

Change From Baseline in Ventilatory Efficiency Defined by Ve/VCO2

Change from baseline in Ventilatory Efficiency defined by Ve/VCO2 (carbon dioxide output) as measured by CPET (NCT02188784)
Timeframe: Measured at BL week 16

InterventionVE/VCO2 Slope (Mean)
Polysaccharide Iron Complex 150 mg-0.48
Placebo (for Polysaccharide Iron Complex 150 mg)-1.31

Change in Peak VO2 (ml/Min) (VO2 =Oxygen Consumption)

To determine if oral Fe (Iron) polysaccharide is superior to oral placebo in improving functional capacity as measured by change in peak VO2 by CPET (Cardiopulmonary Exercise Testing) , of a broad population of patients with HFrEF (Heart Failure with Reduced Ejection Fraction) and Fe deficiency at 16 weeks. (NCT02188784)
Timeframe: Baseline (BL) and Week 16

InterventionmL/min (Mean)
Polysaccharide Iron Complex 150 mg28.04
Placebo (for Polysaccharide Iron Complex 150 mg)3.90

Change in Plasma NT-pro BNP

To determine the impact of oral Fe repletion on Plasma N-terminal pro-B-type natriuretic peptide (NT-pro BNP) (NCT02188784)
Timeframe: Measured at Baseline and Week 16

Interventionpg/ml (Mean)
Polysaccharide Iron Complex 150 mg119.36
Placebo (for Polysaccharide Iron Complex 150 mg)-70.88

Change From Baseline in Sub-maximal Exercise Capacity as Assessed by the 6 Minute Walk Test (6MWT)

To determine the impact of oral Fe repletion on Submaximal exercise capacity as measured by 6MWT (NCT02188784)
Timeframe: Measured at BL, week 8 and week 16

,
Interventionmeters (Mean)
8 weeks16 weeks
Placebo (for Polysaccharide Iron Complex 150 mg)16.6330.94
Polysaccharide Iron Complex 150 mg12.6510.76

Change in Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) - Clinical Summary Score

"To determine the impact of oral Fe repletion on Health Status: KCCQ.~KCCQ is a 23-item, self administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life for patients with congestive heart failure. It is a predictive tool that tracks how patients are doing if they have weakened heart muscle due to prior heart attacks, heart valve problems, viral infections, or other causes.~The KCCQs questions are used to calculate scores in ten domains. Physical Limitation, Symptom Stability, Frequency, Burden and Total Symptom. Social Limitation, Self-Efficacy, Quality of Life, and Clinical Summary. Overall summary: a combined measure of all the above.~For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status." (NCT02188784)
Timeframe: Measured at Baseline, Week 8 and Week 16

,
Interventionunits on a scale (Mean)
Week 8Week 16
Placebo (for Polysaccharide Iron Complex 150 mg)0.584.11
Polysaccharide Iron Complex 150 mg3.253.42

Research Highlights

Dosage (1)

ArticleYear
The relationship between various exposure metrics for elongate mineral particles (EMP) in the taconite mining and processing industry.
Journal of occupational and environmental hygiene, Volume: 11, Issue: 9
2014
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]