NCT03493685Phase 3Completed

Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

Study sponsor: Travere Therapeutics, Inc. · TVTX

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Open ClinicalTrials.gov record CSV export · Pro

Primary completion2023-03-20Actual

Enrollment · participants371Actual

Source updated2026-04-17Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

Pro unlocks the full available history and CSV export. View Pro features

Posted 2026-04-17 · 1 field changed

Recruitment status changed

− Before

~~Active not recruiting~~

+ After

Completed

Check registry source

Study details

Conditions studied

Focal Segmental Glomerulosclerosis

Treatments or interventions studied

sparsentanDrugAlso known as RE-021
IrbesartanDrugAlso known as Irbesartan Tablets USP

Primary outcomes · main study measures

Read the study measures

measure: Slope of Estimated Glomerular Filtration Rate (eGFR); description: 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.; timeFrame: From Day 1 to Week 108; measure: Percentage of Participants Achieving FSGS Partial Remission Endpoint (FPRE); description: Percentage of participants achieving FPRE, defined as urine protein-to-creatinine ratio (UP/C) ≤1.5 grams/gram (g/g) (170 milligrams per millimoles \[mg/mmol\]) and a \>40% reduction from Baseline was analyzed using a generalized linear model to model probability of achieving FPRE. Missing responses were imputed prior to analysis using multiple imputation. A generalized linear model with appropriate link function was implemented with Baseline log (UP/C), treatment, analysis visit, treatment by analysis visit interaction, and randomization strata as fixed effects. For estimates of probability of achieving FPRE, risk difference, and odds ratio, binomial distribution with logit link was used. For relative risk, Poisson distribution with log link was used. Using Rubin's approach, estimated treatment effects are combined across all imputations to obtain overall estimates for probabilities.; timeFrame: Week 36

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

How to read this history