Page last updated: 2024-10-19

phytic acid and Kidney Failure, Chronic

phytic acid has been researched along with Kidney Failure, Chronic in 5 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.

Kidney Failure, Chronic: The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.

Research Excerpts

ExcerptRelevanceReference
"SNF472 is safe and well tolerated in HD patients after 2 schemes: multiple ascending doses for 1 week and after repeated dosing of 10 mg/kg for 4 weeks."2.90A phase 1b randomized, placebo-controlled clinical trial with SNF472 in haemodialysis patients. ( Campistol, JM; Canals, AZ; Ferrer, MD; Joubert, PH; Maduell, F; Ojeda, R; Perelló, J; Salcedo, C; Torregrosa, V, 2019)
"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)
"Forty patients with chronic renal failure (CRF) were enrolled in this study."1.29Delayed gastric emptying and Helicobacter pylori infection in patients with chronic renal failure. ( Hsu, YH; Kao, CH; Wang, SJ, 1995)

Research

Studies (5)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's1 (20.00)18.2507
2000's0 (0.00)29.6817
2010's2 (40.00)24.3611
2020's2 (40.00)2.80

Authors

AuthorsStudies
Raggi, P2
Bellasi, A1
Bushinsky, D1
Bover, J1
Rodriguez, M1
Ketteler, M1
Sinha, S3
Salcedo, C3
Gillotti, K1
Padgett, C1
Garg, R1
Gold, A1
Perelló, J3
Chertow, GM2
Joubert, PH2
Ferrer, MD2
Canals, AZ2
Maduell, F1
Torregrosa, V1
Campistol, JM1
Ojeda, R1
Kao, CH1
Hsu, YH1
Wang, SJ1

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 Kidney Failure, Chronic

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

3 trials available for phytic acid and Kidney Failure, Chronic

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
A phase 1b randomized, placebo-controlled clinical trial with SNF472 in haemodialysis patients.
    British journal of clinical pharmacology, 2019, Volume: 85, Issue:4

    Topics: Aged; Calcinosis; Cardiomyopathies; Cohort Studies; Dose-Response Relationship, Drug; Drug Administr

2019

Other Studies

1 other study available for phytic acid and Kidney Failure, Chronic

ArticleYear
Delayed gastric emptying and Helicobacter pylori infection in patients with chronic renal failure.
    European journal of nuclear medicine, 1995, Volume: 22, Issue:11

    Topics: Adult; Aged; Breath Tests; Carbon Radioisotopes; Female; Gastric Emptying; Gastrointestinal Diseases

1995