Actively Recruiting
Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis
Led by Travere Therapeutics, Inc. · Updated on 2026-02-27
20
Participants Needed
9
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and capable of giving signed informed consent and complying with study requirements
- Male or female aged 18 years or older
- Kidney transplant recipient with biopsy-proven IgAN or FSGS pattern in graft
- At least 12 months since kidney transplantation
- Urinary protein/creatinine ratio (UPCR) of 0.5 g/g or higher and eGFR ≥ 30 mL/min/1.73 m2
- Use of highly reliable contraception from 7 days before first dose until 30 days after last dose if able to become pregnant
- Systolic blood pressure between 100 and 160 mmHg and diastolic blood pressure between 60 and 100 mmHg at screening
- Stable dosing regimen of ACE inhibitors, ARBs, and/or SGLT2 inhibitors for at least 6 weeks prior to screening
You will not qualify if you...
- Multiorgan transplants except pancreas and corneal transplants
- Unstable immunosuppressive therapy regimen within 6 weeks before Day 1 (except routine changes of CNIs)
- Less than 3 months since antirejection treatment or active rejection
- Active bacterial, fungal, or viral infection or treatment for infection including BK virus, CMV, HIV, Hepatitis B or C within 3 months prior to and during screening
- Current treatment for surgical complications
- History of heart failure NYHA Class II-IV
- Jaundice, hepatitis, or known liver disease
- Malignancy within past 2 years except treated basal or non-metastatic squamous cell skin carcinoma
- History of alcohol or illicit drug use disorder
- Serious allergic reaction to angiotensin II antagonists or endothelin receptor antagonists
- Use of prohibited medications
- Treatment with sparsentan within 12 weeks prior to screening
- Participation in another investigational study within 28 days prior to screening or planned during the study
- Hematocrit below 27%, hemoglobin below 90 g/L, or potassium above 5.5 mmol/L
- Pregnant, planning pregnancy, or breastfeeding
- Inability to adhere to study requirements or swallow study medication whole
- Any other medical condition or abnormal lab value that may interfere with safety or activity evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
3
University of North Carolina Chapel Hill
Morrisville, North Carolina, United States, 27560
Actively Recruiting
4
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
5
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
6
Dallas Nephrology Associates
Dallas, Texas, United States, 75204
Actively Recruiting
7
University of Texas
Galveston, Texas, United States, 27599
Actively Recruiting
8
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
9
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
T
Travere Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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