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)
Travere Therapeutics, Inc.
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.
Description
This is a 46-week, open-label, multicenter, single-group Phase 4 study to determine the safety and efficacy of sparsentan for the treatment of patients post kidney transplantation with IgAN or FSGS with proteinuria (≥ 0.5 g/g). Eligible participants with a kidney transplant receiving stable standard of care (SOC) therapy, including standard immunosuppressive therapy (IST) to prevent graft rejection, will be enrolled to receive sparsentan treatment for 36 weeks. Participants will remain on standard IST for the duration of the study and will stop RAASi prior to initiating sparsentan treatment.…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. * Male and female aged ≥18 years * Participants with a kidney transplant with biopsy-proven IgAN or FSGS histological pattern in the graft. * A period of ≥12 months since kidney transplantation. * UPCR ≥0.5 g/g and eGFR (CKD-EPI creatinine-based formula ≥30 mL/min/1.73 m2. * Participants who can become pregnant, must agree to the use of 1 highly reliable method of contraception from 7 days prior to the first dose of…
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.
Locations (9)
- University of Alabama at BirminghamBirmingham, Alabama
- Cornell Medical CenterNew York, New York
- University of North Carolina Chapel HillMorrisville, North Carolina
- Ohio State UniversityColumbus, Ohio
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
- Dallas Nephrology AssociatesDallas, Texas