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NCT05003986 · ClinicalTrials.gov registry record · Phase 2
Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases
A Phase 2 study of Focal Segmental Glomerulosclerosis and Immunoglobulin A Nephropathy, sponsored by Travere Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
- 20
- Study locations
NCT05003986: Recruiting Phase 2 study of Focal Segmental Glomerulosclerosis and Immunoglobulin A Nephropathy, sponsored by Travere Therapeutics.
NCT05003986 is a Phase 2 study of Focal Segmental Glomerulosclerosis and Immunoglobulin A Nephropathy that is actively recruiting participants, run by Travere Therapeutics. The registered enrollment target is 67 participants, below the 233-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05003986, a Phase 2 study of Focal Segmental Glomerulosclerosis and Immunoglobulin A Nephropathy, is actively recruiting participants, sponsored by Travere Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the safety, efficacy and tolerability of sparsentan oral suspension and tablets, and assess changes in proteinuria after once-daily dosing over 108 weeks.
Primary Outcome
The incidence of TEAEs, SAEs, AEs leading to treatment discontinuation, and AEOIs
Conditions Studied
Interventions
- DRUG Sparsentan
Study Locations (20)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
- Atrium Health Levine Children's Hospital - Charlotte
- Duke Molecular Physiology Institute - Durham
Florida
- University of Miami, Leonard M. Miller School of Medicine - Miami
- Nicklaus Children's Hospital - Miami
New Jersey
- Hackensack University Medical Center - Hackensack
- Jersey Shore University Medical Center - Neptune City
New York
- Cohen Children's Medical Center - New Hyde Park
- Fink Children's Ambulatory Care Center - New York
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- St. Christopher's Hospital for Children - Philadelphia
California
- Cedars-Sinai Medical Center - Los Angeles
Delaware
- Nemours Children's Hospital - Wilmington
Iowa
- University of Iowa, Stead Family Children's Hospital - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2021-08-12 |
| Est. Completion | 2027-04-12 |
| Phase | Phase 2 |
What NCT05003986 shows while recruiting
NCT05003986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 233-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (71% lower).
The record links to 5 conditions, with Focal Segmental Glomerulosclerosis appearing as the primary indexed condition, and to 1 intervention - of which Sparsentan is the first listed.
NCT05003986 names 20 study sites across 14 states, led by North Carolina, Florida, New Jersey.
Frequently Asked Questions
What is clinical trial NCT05003986 about?
NCT05003986 is a clinical study titled "Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases". To evaluate the safety, efficacy and tolerability of sparsentan oral suspension and tablets, and assess changes in proteinuria after once-daily dosing over 108 weeks.
What is the current status of trial NCT05003986?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2021-08-12. Estimated completion is 2027-04-12.
What conditions does trial NCT05003986 study?
This clinical trial studies the following conditions: Focal Segmental Glomerulosclerosis, Immunoglobulin A Nephropathy, Minimal Change Disease, IgA Vasculitis, Alport Syndrome.
What interventions are being tested in trial NCT05003986?
The interventions under investigation include: Sparsentan (DRUG).
Who is sponsoring clinical trial NCT05003986?
This trial is sponsored by Travere Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05003986 being conducted?
This trial has 20 study locations across California, Delaware, Florida, Iowa, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05003986's enrollment target sits among peer trials
67 10th of 19 higher than 10 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
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