Phase 2
N=274
Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)
Cardiovascular Diseases · Cardiovascular Abnormalities · Calcifications, Vascular · Endstage Renal Disease · ESRD
Bottom Line
View on ClinicalTrials.gov: NCT02966028 ↗Enrolled (actual)
274
Serious AEs
52.0%
Results posted
Mar 2021
Primary outcome: Primary: Change in Log CAC Volume Score From Baseline to Week 52 for the Combined Dose Groups vs Placebo — 1.11; 1.20 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SNF472 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanifit Therapeutics S. A.
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Log CAC Volume Score From Baseline to Week 52 for the Combined Dose Groups vs Placebo |
1.11; 1.20 | — |
| SECONDARY Change in Log CAC Volume Score From Baseline to Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo |
1.12; 1.10; 1.20 | — |
| SECONDARY 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; 1.13; 1.11; 1.20 | — |
| SECONDARY 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 | — |
| SECONDARY 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 | — |
| SECONDARY 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; 1.21; 1.23; 1.28 | — |
| SECONDARY 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; 1.28; 1.29; 1.32 | — |
| SECONDARY 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; 1.01; 1.14; 1.98 | — |
| SECONDARY 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; 0.98; 1.14; 2.86 | — |
| SECONDARY 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 | — |
| SECONDARY Mortality Rate (All-cause) for Each Dose Group and Placebo |
1; 6; 7; 5 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- Female or male patients, 18 to 80 years (inclusive) of age at randomisation
- CAC score of 100 to 3500 AU (Agatston Units) inclusive within a 3-week period prior to randomisation as measured by a multi-detector CT scanner
- Patients who are EITHER ≥ 55 years OR have a history of diabetes mellitus at randomisation
- Patients on HD for ≥ 6 months prior to randomisation
- Willing and able to understand and sign the informed consent
Exclusion Criteria
- Scheduled date for kidney transplant from a known living donor
- Weight above 300 lbs (136 kg)
- Hospitalisation in the previous 3 months prior to randomisation for unstable angina, MI, stroke, transient ischaemic attack, amputation or peripheral or coronary bypass surgery
- History of unstable heart failure in the previous 3 months, defined as an unplanned presentation to a hospital or dialysis treatment facility with signs/symptoms of acute pulmonary edema and requiring ultrafiltration therapy
- History of cancer that has been in remission for 100 mmHg within the last 2 months proximal to screening expected survival < 2 years in the Investigator's medical opinion
- Known active drug or alcohol abuse within 1 year of randomisation
- Use of other investigational drugs within 30 days of randomisation
- Non-compliance with dialysis treatment which, in the opinion of the Investigator, evidenced by either repeated missed dialysis treatments or significant non-compliance with the patient's medication regimen
- Inability to comply with all required study procedures and schedule, inability to speak and read in the protocol-derived language of that patient's clinical site, or unwillingness or inability to give written informed consent
Data sourced from ClinicalTrials.gov (NCT02966028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.