NCT03762850Phase 3Active not recruiting

A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy

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.

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Primary completion2023-08-07Actual

Enrollment · participants406Actual

Source updated2026-04-20Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Immunoglobulin A Nephropathy

Treatments or interventions studied

sparsentanDrugAlso known as RE-021
irbesartanDrugAlso known as Irbesartan Tablets USP
DapagliflozinDrug

Primary outcomes · main study measures

Read the study measures

measure: Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36; description: 24-hour urine sample was collected for analysis of UP/C via a mixed-model repeated-measures (MMRM) analysis. Missing responses were imputed prior to analysis using multiple imputation. Change from Baseline during the double-blind period in UP/C on the log scale was the dependent variable. Log Baseline UP/C was included as a covariate along with fixed effects for randomized treatment, time (ie, nominal visit in weeks), randomized treatment-by-time interaction, and randomization strata with participants as random effect. Estimates in log scale were back transformed. Baseline was defined as the last non-missing observation on or prior to the start of the dosing. Using Rubin's approach, estimated treatment effects are combined across all imputations to obtain overall estimates.; timeFrame: Baseline (Day 1) and at 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.

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