A Phase 2 interventional study of SNF472 and Placebo in Cardiovascular Diseases, Cardiovascular Abnormalities and Calcifications, Vascular, sponsored by Sanifit Therapeutics S. A.. Completed at 75 sites in 3 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-15.
Sponsored by Sanifit Therapeutics S. A. · Phase 2, Interventional, and Treatment
The primary objective is to assess the effect of 2 dose levels of SNF472 (300 mg and 600 mg) compared to placebo on the progression of coronary artery calcium volume score over a 12-month (52 weeks) period in ESRD patients on HD
Reducing the progression of cardiovascular calcification (CVC) in HD patients may improve the severe burden of CV disease related to the underlying ESRD. As no therapy is currently indicated to target CVC, there is a need to investigate the ability of SNF472 to reduce CVC progression and, ultimately, to improve CV outcomes in HD patients. This phase 2b double-blind, randomised, placebo-controlled study is designed to assess the effect of SNF472 on the progression of CVC as measured by calcium volume and CAC/Agatston scores in ESRD patients receiving HD. The study hypothesis is that administration of SNF472 over 52 weeks can slow the progression of CVC in this patient population compared to placebo.
64 studies on the registry are indexed under Cardiovascular Abnormalities; 15 are open to participants now.
This study's enrollment of 274 is above the median of 66 across 36 interventional studies indexed under Cardiovascular Abnormalities.
Browse Cardiovascular Abnormalities studies →Sanifit Therapeutics S. A. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Compared within Cardiovascular Abnormalities, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cardiovascular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose 1 arm (300 mg): 1 vial of physiological saline and 1 vial of active (10 mL SNF472 at 30 mg/mL)
Drug: SNF472
Dose 2 arm (600 mg): 2 vials of active (10 mL SNF472 at 30 mg/mL)
Drug: SNF472
Placebo arm: 2 vials of physiological saline
Drug: Placebo
Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
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.
Time frame: Baseline (Week 1, Day 1) and Week 52
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.
Time frame: Baseline (Week 1, Day 1) and Week 52
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.
Time frame: Baseline (Week 1, Day 1) and Week 52
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.
Time frame: Baseline (Week 1, Day 1) and Week 52
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.
Time frame: Baseline (Week 1, Day 1) and Week 52
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.
Time frame: Baseline (Week 1, Day 1) and Week 52
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.
Time frame: Baseline (Week 1, Day 1) and Week 52
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.
Time frame: Baseline (Week 1, Day 1) and Week 52
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.
Time frame: Baseline (Week 1, Day 1) and Week 52
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 .
Time frame: Baseline (Week 1, Day 1) and Week 52
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.
Time frame: Baseline (Week 1, Day 1) and Week 52
| Milestone | SNF472 300 mg | SNF 472 600 mg | Matching Placebo |
|---|---|---|---|
| Started | 92 | 91 | 91 |
| Completed | 68 | 57 | 60 |
| Not completed | 24 | 34 | 31 |
| Withdrew: Adverse event | 7 | 13 | 10 |
| Withdrew: Physician decision | 1 | 0 | 2 |
| Withdrew: Withdrawal by subject | 7 | 5 | 5 |
| Withdrew: Kidney transplant changed dialysis units | 9 | 16 | 14 |
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.
| ratio | SNF472 300 mg & 600 mg Combined | Matching Placebo |
|---|---|---|
| Change in Log CAC Volume Score From Baseline to Week 52 for the Combined Dose Groups vs Placebo | 1.11 (1.067 to 1.153) | 1.20 (1.138 to 1.262) |
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.
| ratio | SNF472 300 mg | SNF 472 600 mg | Matching Placebo |
|---|---|---|---|
| Change in Log CAC Volume Score From Baseline to Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo | 1.12 (1.060 to 1.175) | 1.10 (1.042 to 1.165) | 1.20 (1.138 to 1.262) |
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.
| ratio | SNF472 300 mg | SNF 472 600 mg | SNF 472 Combined Dose Groups | Matching Placebo |
|---|---|---|---|---|
| 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 | 1.10 (1.027 to 1.170) | 1.13 (1.055 to 1.215) | 1.11 (1.060 to 1.170) | 1.20 (1.122 to 1.278) |
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.
| Participants | SNF472 300 mg | SNF 472 600 mg | SNF 472 Combined Dose Groups | Matching Placebo |
|---|---|---|---|---|
| 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 | 46 | 41 | 87 | 37 |
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.
| Participants | SNF472 300 mg | SNF 472 600 mg | SNF 472 Combined Dose Groups | Matching Placebo |
|---|---|---|---|---|
| Number of Subjects With >=15% Progression in CAC Agatston Score at Week 52 for Each Dose Group and the Combined Dose Groups vs Placebo | 31 | 24 | 55 | 40 |
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.
| ratio | SNF472 300 mg | SNF 472 600 mg | SNF 472 Combined Dose Groups | Matching Placebo |
|---|---|---|---|---|
| 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 | 1.25 (1.156 to 1.346) | 1.21 (1.113 to 1.318) | 1.23 (1.161 to 1.302) | 1.28 (1.187 to 1.381) |
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.
| ratio | SNF472 300 mg | SNF 472 600 mg | SNF 472 Combined Dose Groups | Matching Placebo |
|---|---|---|---|---|
| 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 | 1.30 (1.186 to 1.432) | 1.28 (1.149 to 1.416) | 1.29 (1.201 to 1.384) | 1.32 (1.205 to 1.452) |
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.
| ratio | SNF472 300 mg | SNF 472 600 mg | SNF 472 Combined Dose Groups | Matching Placebo |
|---|---|---|---|---|
| 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 | 1.28 (1.143 to 1.426) | 1.01 (0.899 to 1.144) | 1.14 (1.048 to 1.235) | 1.98 (1.768 to 2.226) |
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.
| ratio | SNF472 300 mg | SNF 472 600 mg | SNF 472 Combined Dose Groups | Matching Placebo |
|---|---|---|---|---|
| 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 | 1.33 (1.141 to 1.541) | 0.98 (0.836 to 1.160) | 1.14 (1.022 to 1.277) | 2.86 (2.449 to 3.349) |
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 .
| Participants | SNF472 300 mg | SNF 472 600 mg | SNF 472 Combined Dose Groups | Matching Placebo |
|---|---|---|---|---|
| Number of Participants With the Composite Safety Endpoint (Cardiovascular Death, Nonfatal Myocardial Infarction, Non-fatal Stroke, Heart Failure or Non-fatal Cardiac Arrest. | 7 | 6 | 13 | 10 |
The number of deaths were counted and expressed by the randomized arm as a % of patients for the safety population.
| Participants | SNF472 300 mg | SNF 472 600 mg | SNF 472 Combined Dose Groups | Matching Placebo |
|---|---|---|---|---|
| Mortality Rate (All-cause) for Each Dose Group and Placebo | 1 | 6 | 7 | 5 |
Collected over Collected over one year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SNF472 300 mg | 1/92 (1.1%) | 38/92 (41.3%) | 62/92 (67.4%) |
| SNF 472 600 mg | 6/91 (6.6%) | 55/91 (60.4%) | 64/91 (70.3%) |
| Matching Placebo | 5/90 (5.6%) | 49/90 (54.4%) | 67/90 (74.4%) |
| Event | SNF472 300 mg | SNF 472 600 mg | Matching Placebo |
|---|---|---|---|
| Renal TransplantSurgical and medical procedures | 6/92 | 14/91 | 11/90 |
| PneumoniaInfections and infestations | 4/92 | 3/91 | 7/90 |
| Acute myocardial infarctionCardiac disorders | 1/92 | 1/91 | 4/90 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/92 | 4/91 | 0/90 |
| Fluid overloadMetabolism and nutrition disorders | 1/92 | 1/91 | 3/90 |
| Chest painGeneral disorders | 1/92 | 0/91 | 3/90 |
| Arteriovenous fistula site complicationInjury, poisoning and procedural complications | 1/92 | 3/91 | 1/90 |
| Atrial fibrillationCardiac disorders | 3/92 | 3/91 | 2/90 |
| Cardiac arrestCardiac disorders | 1/92 | 3/91 | 0/90 |
| Atrial flutterCardiac disorders | 0/92 | 3/91 | 0/90 |
| Event | SNF472 300 mg | SNF 472 600 mg | Matching Placebo |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 7/92 | 11/91 | 10/90 |
| Abdominal pain upperGastrointestinal disorders | 11/92 | 2/91 | 2/90 |
| CoughRespiratory, thoracic and mediastinal disorders | 10/92 | 9/91 | 8/90 |
| VomitingGastrointestinal disorders | 1/92 | 8/91 | 4/90 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 7/92 | 7/91 | 7/90 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 5/92 | 7/91 | 7/90 |
| Upper respiratory tract infectionInfections and infestations | 2/92 | 4/91 | 6/90 |
| NasopharyngitisInfections and infestations | 3/92 | 1/91 | 6/90 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 3/92 | 6/91 | 5/90 |
| Back painMusculoskeletal and connective tissue disorders | 6/92 | 2/91 | 4/90 |
One subject randomized to placebo discontinued from the trial prior to the initiation of the study drug. The number of subjects treated and analyzed was 273 and the number of subjects randomized was 274.
| Age, Categorical(Participants) | SNF472 300 mg | SNF 472 600 mg | Matching Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 54 | 51 | 40 | 145 |
| >=65 years | 38 | 40 | 50 | 128 |
| Age, Continuous(years) | SNF472 300 mg | SNF 472 600 mg | Matching Placebo | Total |
|---|---|---|---|---|
| Mean | 63 ± 9.5 | 64 ± 8.9 | 64. ± 8.2 | 63.5 ± 8.9 |
| Sex: Female, Male(Participants) | SNF472 300 mg | SNF 472 600 mg | Matching Placebo | Total |
|---|---|---|---|---|
| Female | 38 | 36 | 33 | 107 |
| Male | 54 | 55 | 57 | 166 |
| Ethnicity (NIH/OMB)(Participants) | SNF472 300 mg | SNF 472 600 mg | Matching Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 31 | 36 | 32 | 99 |
| Not Hispanic or Latino | 60 | 51 | 56 | 167 |
| Unknown or Not Reported | 1 | 4 | 2 | 7 |
| Race (NIH/OMB)(Participants) | SNF472 300 mg | SNF 472 600 mg | Matching Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 0 | 2 |
| Asian | 2 | 4 | 4 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Black or African American | 27 | 15 | 19 | 61 |
| White | 59 | 67 | 62 | 188 |
| More than one race | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 1 | 4 | 5 | 10 |
| Region of Enrollment(participants) | SNF472 300 mg | SNF 472 600 mg | Matching Placebo | Total |
|---|---|---|---|---|
| United States | 58 | 53 | 54 | 165 |
| United Kingdom | 6 | 3 | 5 | 14 |
| Spain | 28 | 35 | 31 | 94 |
| CAC Agatston Score(units on a scale) | SNF472 300 mg | SNF 472 600 mg | Matching Placebo | Total |
|---|---|---|---|---|
| Mean | 917 ± 697 | 963 ± 702 | 965 ± 762 | 948 ± 744 |
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: SNF472
Cardiovascular Abnormalities →
Sanifit Therapeutics S. A.