Page last updated: 2024-10-19

phytic acid and Vascular Calcification

phytic acid has been researched along with Vascular Calcification in 8 studies

Phytic Acid: Complexing agent for removal of traces of heavy metal ions. It acts also as a hypocalcemic agent.
myo-inositol hexakisphosphate : A myo-inositol hexakisphosphate in which each hydroxy group of myo-inositol is monophosphorylated.

Vascular Calcification: Deposition of calcium into the blood vessel structures. Excessive calcification of the vessels are associated with ATHEROSCLEROTIC PLAQUES formation particularly after MYOCARDIAL INFARCTION (see MONCKEBERG MEDIAL CALCIFIC SCLEROSIS) and chronic kidney diseases which in turn increase VASCULAR STIFFNESS.

Research Excerpts

ExcerptRelevanceReference
"It is a potential novel treatment for cardiovascular calcification in end-stage renal disease and calciphylaxis warranting further human studies."2.87First-time-in-human randomized clinical trial in healthy volunteers and haemodialysis patients with SNF472, a novel inhibitor of vascular calcification. ( Canals, AZ; Ferrer, MD; Joubert, PH; Perelló, J; Salcedo, C; Sinha, S, 2018)
" Further prospective studies must be performed to elucidate the benefits of a phytate-rich diet and the associated risk of phosphorus bioavailability in these patients."1.43Protective Effect of Myo-Inositol Hexaphosphate (Phytate) on Abdominal Aortic Calcification in Patients With Chronic Kidney Disease. ( Berga, F; Bernabeu, MR; Buades, JM; Costa-Bauzá, A; García, S; Gelabert, MM; Gonzalez, J; Grases, F; Íñigo, MV; Molina, M; Sanchis, P, 2016)

Research

Studies (8)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's4 (50.00)24.3611
2020's4 (50.00)2.80

Authors

AuthorsStudies
Raggi, P2
Bellasi, A1
Bushinsky, D1
Bover, J1
Rodriguez, M1
Ketteler, M2
Sinha, S3
Salcedo, C5
Gillotti, K1
Padgett, C1
Garg, R2
Gold, A2
Perelló, J5
Chertow, GM2
Hedayati, SS1
Ferrer, MD3
Del Mar Pérez, M1
Kaesler, N1
Brandenburg, VM1
Behets, GJ1
D'Haese, PC1
Isern, B1
Wolf, M1
Gómez, M1
Rodríguez, NY1
Buades, JM2
Pérez, MM1
Torregrosa, JV1
Martín, E1
Maduell, F1
Joubert, PH1
Canals, AZ1
Sanchis, P1
Berga, F1
Gelabert, MM1
Molina, M1
Íñigo, MV1
García, S1
Gonzalez, J1
Bernabeu, MR1
Costa-Bauzá, A1
Grases, F1
Joubert, P1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Double-blind, Randomised, Placebo-controlled Study to Assess the Effect of SNF472 on Progression of Cardiovascular Calcification on Top of Standard of Care in End-stage-renal-disease (ESRD) Patients on Hemodialysis (HD)[NCT02966028]Phase 2274 participants (Actual)Interventional2016-11-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change in Log Aortic Valve Calcification Agatston Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo

Coronary Artery Calcification (CAC) Agatston Score is a semi-automated tool to calculate a score the reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to >1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. This secondary outcome measure was the change in Log CAC Agatston Score or the aortic valve from Baseline to Week 52 for each dose group and the treated arms combined vs placebo. The analysis used an ANCOVA model with the change in log score (log 52-week score - log baseline score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC score at baseline as a covariate. The least squares means for each of the treatment groups separately and combined was estimated and back transformed. A smaller change from baseline to follow up is a better outcome. (NCT02966028)
Timeframe: Baseline (Week 1, Day 1) and Week 52

Interventionratio (Geometric Least Squares Mean)
SNF472 300 mg1.33
SNF 472 600 mg0.98
SNF 472 Combined Dose Groups1.14
Matching Placebo2.86

Change in Log Aortic Valve Calcification Volume Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo

"Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC volume score observed in the aortic valve was used for this analysis. The CAC volume Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups and each dose group vs placebo. The secondary analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for the combined randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for the treatment groups was estimated and back transformed.~A smaller change from baseline to follow up is a better outcome." (NCT02966028)
Timeframe: Baseline (Week 1, Day 1) and Week 52

Interventionratio (Geometric Least Squares Mean)
SNF472 300 mg1.28
SNF 472 600 mg1.01
SNF 472 Combined Dose Groups1.14
Matching Placebo1.98

Change in Log CAC Agatston Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and for the Combined Dose Groups vs the Placebo Group

Coronary Artery Calcification (CAC) Agatston Score is a semi-automated tool to calculate a score the reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to >1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. This secondary outcome measure was the change in Log CAC Agatston Score from Baseline to Week 52 for each dose group and the treated arms combined vs placebo. The analysis used an ANCOVA model with the change in log score (log 52-week score - log baseline score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC score at baseline as a covariate. The least squares means for each of the treatment groups separately and combined was estimated and back transformed. (NCT02966028)
Timeframe: Baseline (Week 1, Day 1) and Week 52

Interventionratio (Geometric Least Squares Mean)
SNF472 300 mg1.10
SNF 472 600 mg1.13
SNF 472 Combined Dose Groups1.11
Matching Placebo1.20

Change in Log CAC Volume Score From Baseline to Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo

"Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups vs placebo. This secondary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for each dose group vs placebo. The analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for each of the treatment groups was estimated and back transformed.~A smaller change from baseline to follow up is a better outcome." (NCT02966028)
Timeframe: Baseline (Week 1, Day 1) and Week 52

Interventionratio (Geometric Least Squares Mean)
SNF472 300 mg1.12
SNF 472 600 mg1.10
Matching Placebo1.20

Change in Log CAC Volume Score From Baseline to Week 52 for the Combined Dose Groups vs Placebo

"Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups vs placebo. The primary analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for the combined randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for the treatment groups was estimated and back transformed.~A smaller change from baseline to follow up is a better outcome." (NCT02966028)
Timeframe: Baseline (Week 1, Day 1) and Week 52

Interventionratio (Geometric Least Squares Mean)
SNF472 300 mg & 600 mg Combined1.11
Matching Placebo1.20

Change in Log Thoracic Aorta Calcification Agatston Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo

Coronary Artery Calcification (CAC) Agatston Score is a semi-automated tool to calculate a score that reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to >1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. This secondary outcome measure was the change in CAC Agatston Score in the thoracic aorta from Baseline to Week 52 for each dose group and the treated arms combined vs placebo. The analysis used an ANCOVA model with the change in log score (log 52-week score - log baseline score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC score at baseline as a covariate. The least squares means for each of the treatment groups separately and combined was estimated and back transformed. A smaller change from baseline to follow up is a better outcome. (NCT02966028)
Timeframe: Baseline (Week 1, Day 1) and Week 52

Interventionratio (Geometric Least Squares Mean)
SNF472 300 mg1.30
SNF 472 600 mg1.28
SNF 472 Combined Dose Groups1.29
Matching Placebo1.32

Change in Log Thoracic Aorta Calcification Volume Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo

"Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC volume score observed in the thoracic aorta was used for this analysis. The CAC volume Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups and each dose group vs placebo. The secondary analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for the combined randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for the treatment groups was estimated and back transformed.~A smaller change from baseline to follow up is a better outcome." (NCT02966028)
Timeframe: Baseline (Week 1, Day 1) and Week 52

Interventionratio (Geometric Least Squares Mean)
SNF472 300 mg1.25
SNF 472 600 mg1.21
SNF 472 Combined Dose Groups1.23
Matching Placebo1.28

Mortality Rate (All-cause) for Each Dose Group and Placebo

The number of deaths were counted and expressed by the randomized arm as a % of patients for the safety population. (NCT02966028)
Timeframe: Baseline (Week 1, Day 1) and Week 52

InterventionParticipants (Count of Participants)
SNF472 300 mg1
SNF 472 600 mg6
SNF 472 Combined Dose Groups7
Matching Placebo5

Number of Participants With the Composite Safety Endpoint (Cardiovascular Death, Nonfatal Myocardial Infarction, Non-fatal Stroke, Heart Failure or Non-fatal Cardiac Arrest.

The number of subjects meeting this composite safety endpoint were counted and expressed by the randomized arm as a % of patients for the safety population.terms resulting in death from cardiovascular causes, myocardial infarction, stroke, or heart failure for each dose group and placebo were summarized . (NCT02966028)
Timeframe: Baseline (Week 1, Day 1) and Week 52

InterventionParticipants (Count of Participants)
SNF472 300 mg7
SNF 472 600 mg6
SNF 472 Combined Dose Groups13
Matching Placebo10

Number of Subjects With <15% Progression in CAC Agatston Score From Baseline to Week 52 for Each Dose Group and the Combined Dose Groups vs Placebo

Agatston score is a semi-automated tool to calculate a score that reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to >1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. Change in Agatston Score values from baseline to Week 52 were calculated as a percentage of change (progression or worsening of calcification). The number of subjects with <15% progression were counted. (NCT02966028)
Timeframe: Baseline (Week 1, Day 1) and Week 52

InterventionParticipants (Count of Participants)
SNF472 300 mg46
SNF 472 600 mg41
SNF 472 Combined Dose Groups87
Matching Placebo37

Number of Subjects With >=15% Progression in CAC Agatston Score at Week 52 for Each Dose Group and the Combined Dose Groups vs Placebo

Agatston score is a semi-automated tool to calculate a score the reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to >1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. Change in Agatston Score values from baseline to Week 52 was calculated as a percentage of change (progression or worsening of calcification). The number of subjects with >=15% progression were counted for each treatment group, the combined treatments groups and placebo. (NCT02966028)
Timeframe: Baseline (Week 1, Day 1) and Week 52

InterventionParticipants (Count of Participants)
SNF472 300 mg31
SNF 472 600 mg24
SNF 472 Combined Dose Groups55
Matching Placebo40

Reviews

1 review available for phytic acid and Vascular Calcification

ArticleYear
SNF472: mechanism of action and results from clinical trials.
    Current opinion in nephrology and hypertension, 2021, 07-01, Volume: 30, Issue:4

    Topics: Humans; Kidney Failure, Chronic; Phytic Acid; Renal Dialysis; Vascular Calcification

2021

Trials

2 trials available for phytic acid and Vascular Calcification

ArticleYear
Slowing Progression of Cardiovascular Calcification With SNF472 in Patients on Hemodialysis: Results of a Randomized Phase 2b Study.
    Circulation, 2020, 03-03, Volume: 141, Issue:9

    Topics: Aged; Aortic Valve; Coronary Artery Disease; Disease Progression; Double-Blind Method; Durapatite; E

2020
First-time-in-human randomized clinical trial in healthy volunteers and haemodialysis patients with SNF472, a novel inhibitor of vascular calcification.
    British journal of clinical pharmacology, 2018, Volume: 84, Issue:12

    Topics: Adult; Aged; Calcium; Double-Blind Method; Healthy Volunteers; Humans; Kidney Failure, Chronic; Male

2018

Other Studies

5 other studies available for phytic acid and Vascular Calcification

ArticleYear
A Novel Treatment for Vascular Calcification in Patients With Dialysis-Dependent Chronic Kidney Disease: Are We There Yet?
    Circulation, 2020, 03-03, Volume: 141, Issue:9

    Topics: Humans; Phytic Acid; Renal Dialysis; Renal Insufficiency, Chronic; Vascular Calcification

2020
Mechanism of action of SNF472, a novel calcification inhibitor to treat vascular calcification and calciphylaxis.
    British journal of pharmacology, 2020, Volume: 177, Issue:19

    Topics: Animals; Calciphylaxis; Dogs; Humans; Phytic Acid; Rats; Renal Dialysis; Vascular Calcification

2020
SNF472, a novel inhibitor of vascular calcification, could be administered during hemodialysis to attain potentially therapeutic phytate levels.
    Journal of nephrology, 2018, Volume: 31, Issue:2

    Topics: Calcium; Creatinine; Dialysis Solutions; Hemodiafiltration; Humans; Phytic Acid; Renal Dialysis; Vas

2018
Protective Effect of Myo-Inositol Hexaphosphate (Phytate) on Abdominal Aortic Calcification in Patients With Chronic Kidney Disease.
    Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation, 2016, Volume: 26, Issue:4

    Topics: Aged; Aorta, Abdominal; Body Mass Index; Cross-Sectional Studies; Diet; Female; Humans; Male; Middle

2016
Hypothesis: Phytate is an important unrecognised nutrient and potential intravenous drug for preventing vascular calcification.
    Medical hypotheses, 2016, Volume: 94

    Topics: Administration, Oral; Aging; Animals; Diet; Disease Progression; Humans; Infusions, Intravenous; Kid

2016