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NCT03493685 · ClinicalTrials.gov registry record · Phase 3
Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)
A Phase 3 study of Focal Segmental Glomerulosclerosis, sponsored by Travere Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 371
- Enrollment target
- 20
- Study locations
NCT03493685: Active Phase 3 study of Focal Segmental Glomerulosclerosis, sponsored by Travere Therapeutics.
NCT03493685 is a Phase 3 study of Focal Segmental Glomerulosclerosis that is active but no longer recruiting, run by Travere Therapeutics. The registered enrollment target is 371 participants, above the 217-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (71% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03493685, a Phase 3 study of Focal Segmental Glomerulosclerosis, is active but no longer recruiting, sponsored by Travere Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 371 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
The total eGFR slope over 2 years, defined as the slope of eGFR following initiation of randomized treatment (ie, Day 1 to Week 108). Estimates are calculated from a mixed-effects model with treatment, Baseline eGFR, analysis visit, treatment-by-analysis visit, randomization stratification factors as fixed effects, and intercept and slope for each participant as a random effect.
Conditions Studied
Interventions
- DRUG sparsentan
- DRUG Irbesartan
Study Locations (20)
California
- Travere Investigational Site - Los Angeles
- Travere Investigational Site - Northridge
- Travere Investigational Site - Palo Alto
- Travere Investigational Site - San Diego
- Travere Investigational Site - San Dimas
- Travere Investigational Site - San Francisco
- Travere Investigational Site - Torrance
- Travere Investigational Site - Victorville
Florida
- Travere Investigational Site - Coral Springs
- Travere Investigational Site - Fort Lauderdale
- Travere Investigational Site - Gainesville
- Travere Investigational Site - Miami
- Travere Investigational Site - Miami
Arizona
- Travere Investigational Site - Mesa
- Travere Investigational Site - Phoenix
Colorado
- Travere Investigational Site - Denver
- Travere Investigational Site - Denver
Connecticut
- Travere Investigational Site - Middlebury
Delaware
- Travere Investigational Site - Wilmington
District of Columbia
- Travere Investigational Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 371 participants |
| Start Date | 2018-04-17 |
| Est. Completion | 2026-02 |
| Phase | Phase 3 |
What the registry record for NCT03493685 still lists
NCT03493685 is an interventional study that assigns participants to a tested intervention. The registered 371 participants enrollment target is mid-sized for trials with a published cap, above the 217-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (71% higher).
The record links to 1 condition, with Focal Segmental Glomerulosclerosis appearing as the primary indexed condition, and to 2 interventions - of which sparsentan is the first listed.
NCT03493685 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT03493685 about?
NCT03493685 is a clinical study titled "Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)". 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).
What is the current status of trial NCT03493685?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 371 participants. The study started on 2018-04-17. Estimated completion is 2026-02.
What conditions does trial NCT03493685 study?
This clinical trial studies the following conditions: Focal Segmental Glomerulosclerosis.
What interventions are being tested in trial NCT03493685?
The interventions under investigation include: sparsentan (DRUG), Irbesartan (DRUG).
Who is sponsoring clinical trial NCT03493685?
This trial is sponsored by Travere Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03493685 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Focal Segmental Glomerulosclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03493685's enrollment target sits among peer trials
371 4th of 19 higher than 16 of 19 other Focal Segmental Glomerulosclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Focal Segmental Glomerulosclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
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-
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A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
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-
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Primary Focal Segmental Glomerulosclerosis
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