MedTrace Logo

Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)

NCT02966028 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2021-04-15

Study results available
· View outcomes & findings →

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

Conditions

  • Cardiovascular Diseases
  • Cardiovascular Abnormalities
  • Calcifications, Vascular
  • Endstage Renal Disease
  • ESRD
  • Coronary Artery Calcification

Interventions

DRUG

SNF472

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Clinipace Worldwide

    collaborator INDUSTRY

  • Sanifit Therapeutics S. A.

    lead OTHER

Principal Investigators

  • Alex Gold, MD · Sanifit Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-08-31
Completion
2019-09-30

Countries

  • United States
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02966028 on ClinicalTrials.gov