At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 109 enrolled
Drug / intervention
RE-021 (Sparsentan) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Sparsentan (RE-021), a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients With Focal Segmental Glomerulosclerosis (FSGS): a Randomized, Double-Blind, Active-Control, Dose-Escalation Study
In Brief
A Phase 2 clinical trial evaluating RE-021 (Sparsentan) and Irbesartan for Focal Segmental Glomerulosclerosis. Completed, enrolled 109 participants across 33 sites in 3 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFocal Segmental Glomerulosclerosis
CountriesCzechia, Italy, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartMar 2014
Primary CompletionJun 2016
Study CompletionMar 2024
TodayJul 2026
First PostedJun 6, 2012
Enrollment StartMar 1, 2014
Primary CompletionJun 1, 2016
Study CompletionMar 25, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.1 years ago
Interventions
RE-021 (Sparsentan)drug
Oral, once-daily
Irbesartandrug
Oral, once-daily