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NCT01613118 · ClinicalTrials.gov registry record · Phase 2
Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis
A Phase 2 study, sponsored by Travere Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 109
- Enrollment target
NCT01613118: Completed Phase 2 study, sponsored by Travere Therapeutics.
NCT01613118 is a Phase 2 study that has completed, run by Travere Therapeutics. The registered enrollment target is 109 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01613118, a Phase 2 study, has completed, sponsored by Travere Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 109 participants
- Enrollment target
Study Summary
This study will investigate whether RE-021 (Sparsentan), a selective dual-acting receptor antagonist with affinity for endothelin (A type) and angiotensin II receptors (Type 1), is safe and effective in treating patients with focal segmental glomerulosclerosis (FSGS).
Primary Outcome
Primary efficacy objective is to determine the change in UP/C in FSGS patients receiving RE-021 (Sparsentan) from baseline to 8 weeks over a range of dose levels compared to treatment with irbesartan as active control.
Interventions
- DRUG Irbesartan
- DRUG RE-021 (Sparsentan)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2014-03 |
| Est. Completion | 2024-03-25 |
| Phase | Phase 2 |
What the finished NCT01613118 record still lists
NCT01613118 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 2 interventions - of which Irbesartan is the first listed.
NCT01613118 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01613118 about?
NCT01613118 is a clinical study titled "Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis". This study will investigate whether RE-021 (Sparsentan), a selective dual-acting receptor antagonist with affinity for endothelin (A type) and angiotensin II receptors (Type 1), is safe and effective in treating patients with focal segmental glomerulosclerosis (FSGS).
What is the current status of trial NCT01613118?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2014-03. Estimated completion is 2024-03-25.
What interventions are being tested in trial NCT01613118?
The interventions under investigation include: Irbesartan (DRUG), RE-021 (Sparsentan) (DRUG).
Who is sponsoring clinical trial NCT01613118?
This trial is sponsored by Travere Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01613118's enrollment target sits among peer trials
109 640th of 2000 higher than 1,361 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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