CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 274 enrolled
Drug / intervention
SNF472 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02966028
NCT02966028Phase 2Completed
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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)

Sanifit Therapeutics S. A.·interventional·Posted Nov 17, 2016·Updated Apr 15, 2021

In Brief

A Phase 2 clinical trial evaluating SNF472 and Placebo for Cardiovascular Diseases and 5 related conditions. Completed, enrolled 274 participants across 75 sites in 3 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Diseases, Cardiovascular Abnormalities, Calcifications, Vascular, Endstage Renal Disease, ESRD, Coronary Artery Calcification
CountriesSpain, United Kingdom, United States
CollaboratorsClinipace Worldwide

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 17, 2016
Enrollment StartNov 1, 2016
Primary CompletionAug 1, 2019
Study CompletionSep 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.6 years ago

Interventions

SNF472drug

Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.

Placebodrug

Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.