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Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

NCT03493685 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 371

Last updated 2026-04-17

Study results available
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Summary

To determine the long-term nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with primary and genetic focal segmental glomerulosclerosis (FSGS).

Conditions

  • Focal Segmental Glomerulosclerosis

Interventions

DRUG

sparsentan

Double-blind period: target dose of 800 mg daily; Open-label extension: target dose based on dosage from week 114 daily

DRUG

Irbesartan

target dose of 300 mg daily

Sponsors & Collaborators

  • Travere Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Radko Komers, MD, PhD · Travere Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-17
Primary Completion
2023-03-20
Completion
2026-03-19
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Hong Kong
  • Italy
  • New Zealand
  • Poland
  • Portugal
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

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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 NCT03493685 on ClinicalTrials.gov