Sparsentan for Kidney Transplant Patients with IgA Nephropathy or FSGS
This study is testing sparsentan to see how safe and effective it is for people who have had a kidney transplant and now have proteinuria (too much protein in their urine) due to IgA nephropathy or focal segmental glomerulosclerosis (FSGS). Participants will take sparsentan once daily for 36 weeks. The study aims to see if sparsentan can reduce the amount of protein in your urine. You might be able to join if you are over 18, have had a kidney transplant at least a year ago, and have biopsy-proven IgA nephropathy or FSGS with proteinuria. The study is currently unclear on its recruitment status.
- Study design
- This is an open-label, single-group study with 20 planned participants. It is a Phase 4 study, meaning it's testing a drug that has already been approved for other uses.
- What's involved
- You will take sparsentan daily for 36 weeks, starting with a lower dose and increasing it. You will have study visits on Day 5 and at Weeks 2, 4, 6, 12, 24, and 36.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the 36-week treatment, you will have a 4-week follow-up period without the study drug.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07219121
Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis
Active, Not Recruiting
PHASE4Ages 18+InterventionalTreatmentTravere Therapeutics, Inc.
~20 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Sparsentan
At a glance
Recruiting sites
0 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Urinary protein/creatinine ratio (UPCR)
Measured over 36 weeks
Conditions
Where it's being run
8 sites across 7 statesTexas2
Alabama1
New York1
North Carolina1
Ohio1
Washington1
Wisconsin1
Study leadership
- Radko Komers, MD, PhD · STUDY_DIRECTOR · Travere Therapeutics
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 study intervention until 30 days after the last dose of study intervention.
Systolic BP ≤160 mmHg and ≥100 mmHg, and diastolic BP ≤100 mmHg and ≥60 mmHg at screening.
For participants on an ACEI and/or ARB, and/or sodium glucose cotransporter-2 (SGLT2) inhibitor, the dosing regimen(s) is stable for ≥6 weeks prior to screening.
Exclusion
Participant has multiorgan transplants (with the exception of pancreas and corneal transplants).
Immunosuppressive therapy (IST) regimen for kidney transplant or other systemic chronic ISTs including enteric budesonide that is not stable for \>6 weeks prior to Day 1. Exceptions include routine changes in the dose of CNIs to meet target level.
\<3 months after antirejection treatment and active rejection.
Active bacterial, fungal or viral infection and/or active treatment of infection including BK virus (BKV), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B and C \<3 months prior to and during the screening period.
Current treatment for surgical complications.
History of heart failure (New York Heart Association \[NYHA\] Class II-IV).
Jaundice, hepatitis, or known hepatobiliary disease.
Malignancy within the past 2 years with the exception of adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin, with no evidence or recurrence.
History of alcohol or illicit drug use disorder (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition).
History of serious side effects or allergic response to any angiotensin II antagonist or ERA.
Participant requires any of the prohibited concomitant medications.
Treatment with sparsentan \<12 weeks prior to screening.
Participant has participated in a study of another investigational product \<28 days prior to screening or plans to participate in such a study during the course of this study.
Hematocrit \<27%, hemoglobin \<90 g/L (9 g/dL), or potassium \>5.5 mmol/L (5.5 mEq/L).
The participant is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.
The participant, in the opinion of the Investigator, is unable to adhere to the requirements of the study, including the ability to swallow the study IMP whole.
The participant, in the opinion of the Investigator, has a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity.
What this trial measures
- Urinary protein/creatinine ratio (UPCR)36 weeks
Change from baseline (Day 1) in urinary protein/creatinine ratio (UPCR) to Week 36.