RecruitingPhase 4NCT07219121

Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis

A Multicenter, Open-label Single Arm Study to Evaluate the Safety and Efficacy of Sparsentan in Posttransplant Immunoglobulin A Nephropathy (IgAN) or Focal Segmental Glomerulosclerosis (FSGS) (SPARX)

Sponsor

Travere Therapeutics, Inc.

Enrollment

20 participants

Start Date

Oct 7, 2025

Study Type

INTERVENTIONAL

Conditions

Kidney Transplant Focal Segmental Glomerulosclerosis Proteinuria Immunoglobulin A (IgA) Nephropathy

Summary

To evaluate the safety and efficacy of sparsentan tablets for the treatment of patients with proteinuria after kidney transplantation with once-daily dosing for 36 weeks.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Sparsentan for people with focal segmental glomerulosclerosis, immunoglobulin a (iga) nephropathy, and other related conditions. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSparsentan

For participants with a kidney transplant with IgAN: Day 1 through Week 2 visit, participants will take 200 mg once daily (QD) prior to the morning meal. At the Week 2 visit, participants will titrate up to 400 mg QD and take this dose through Week 36, if tolerated and determined to be safe by the Investigator. For participants with a kidney transplant with FSGS, or a biopsy finding of both IgAN and glomeruli with FSGS patterns: Day 1 through Week 2 visit, participants will take 400 mg QD prior to the morning meal. At the Week 2 visit, participants will titrate up to 800 mg QD and take this dose through Week 36, if tolerated and determined to be safe by the Investigator.