At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 371 enrolled
Drug / intervention
sparsentan +1 moredrug
Likely dose
sparsentan 800 mgfrom 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.
A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGS
In Brief
A Phase 3 clinical trial evaluating sparsentan and Irbesartan for Focal Segmental Glomerulosclerosis. Completed, enrolled 371 participants across 226 sites in 22 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFocal Segmental Glomerulosclerosis
CountriesArgentina, Australia, Belgium, Brazil, Canada, Croatia, Czechia, Denmark, Estonia, France, Germany, Hong Kong, Italy, New Zealand, Poland, Portugal, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedApr 2018
Enrollment StartApr 2018
Primary CompletionMar 2023
Study CompletionMar 2026
TodayJul 2026
First PostedApr 10, 2018
Enrollment StartApr 17, 2018
Primary CompletionMar 20, 2023
Study CompletionMar 19, 2026
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 8.2 years ago
Interventions
sparsentandrug
Double-blind period: target dose of 800 mg daily; Open-label extension: target dose based on dosage from week 114 daily
Irbesartandrug
target dose of 300 mg daily