Status:
RECRUITING
Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis
Lead Sponsor:
Travere Therapeutics, Inc.
Conditions:
Proteinuria
Immunoglobulin A (IgA) Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Detailed 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 wi...
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.
Key Trial Info
Start Date :
October 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07219121
Start Date
October 7 2025
End Date
May 1 2027
Last Update
December 19 2025
Active Locations (8)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Cornell Medical Center
New York, New York, United States, 10065
3
University of North Carolina Chapel Hill
Mooresville, North Carolina, United States, 27560
4
Ohio State University
Columbus, Ohio, United States, 43210