NCT01613118Phase 2Completed

Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis

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 completion2016-06Actual

Enrollment · participants109Actual

Source updated2025-05-15Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Focal Segmental Glomerulosclerosis

Treatments or interventions studied

RE-021 (Sparsentan)DrugAlso known as Sparsentan
IrbesartanDrugAlso known as Avapro

Primary outcomes · main study measures

measure: Percent Change in Urine Protein/Creatinine (Up/C); description: 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.; timeFrame: 8 weeks

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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