Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis (NCT07219121)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (18 items).
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (8 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- Cornell Medical Center — New York, New York
- University of North Carolina Chapel Hill — Morrisville, North Carolina
- Ohio State University — Columbus, Ohio
- Dallas Nephrology Associates — Dallas, Texas
- University of Texas — Galveston, Texas
- University of Washington — Seattle, Washington
- University of Wisconsin — Madison, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Proteinuria in Pre and Post Transplant — Miami, Florida
Explore by condition: All Proteinuria clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.