Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases (NCT05003986)

🧪 Interventions in This Study

• Sparsentan (DRUG)
• Sparsentan (DRUG)
• Sparsentan (DRUG)

Check 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).

1. for All Subjects (All Three Populations): A subject must meet all of the following criteria to be eligible for participation in this study:
2. The subject or parent/legal guardian (as appropriate) is willing and able to provide signed informed consent/assent, and where required, the subject is willing to provide assent before any screening procedures per local requirements.
3. The subject has an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening.
4. The subject has a mean seated blood pressure between the 5th and 95th percentile for sex and height. Inclusion Criteria for Population 1:
5. The subject is male or female ≥1 year at screening and \<18 years of age at Day 1 (Baseline).
6. The subject has a UP/C ≥1.5 g/g (170 mg/mmol) at screening AND one of the following:
7. Kidney biopsy-proven FSGS or MCD histological patterns and clinical presentation consistent with primary FSGS or MCD and qualifying proteinuria at screening despite history or ongoing treatment with corticosteroids and/or other immunosuppressive disease-modifying agents.
8. Documentation of a genetic mutation in a podocyte protein associated with FSGS or MCD. Subjects with a documented podocytic mutation do not require kidney biopsy.
9. Kidney biopsy-proven FSGS histological pattern with medical history and clinical presentation consistent with maladaptive cause of the lesion. Note: The kidney biopsy may have been performed at any time in the past but must include light microscopy and electron microscopy characteristics and/or immunofluorescence findings consistent with FSGS or MCD. Inclusion Criteria for Population 2:
10. The subject is male or female ≥2 years at screening and \<18 years of age at Day 1 (Baseline).
11. The subject has UP/C ≥0.6 g/g (68 mg/mmol) at screening AND one of the following diagnoses:
12. Kidney biopsy-confirmed IgAN, IgAV, or AS

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (47 Sites)

Showing the first 25 of 47 sites.

• Cedars-Sinai Medical Center — Los Angeles, California
• Nemours Children's Hospital — Wilmington, Delaware
• University of Miami, Leonard M. Miller School of Medicine — Miami, Florida
• Nicklaus Children's Hospital — Miami, Florida
• University of Iowa, Stead Family Children's Hospital — Iowa City, Iowa
• Floating Hospital for Children at Tufts Medical Center — Boston, Massachusetts
• C.S. Mott Children's Hospital — Ann Arbor, Michigan
• University of Minnesota, Masonic Children's Hospital — Minneapolis, Minnesota
• Children's Mercy Hospitals and Clinics — Kansas City, Missouri
• Hackensack University Medical Center — Hackensack, New Jersey
• Jersey Shore University Medical Center — Neptune City, New Jersey
• Cohen Children's Medical Center — New Hyde Park, New York
• Fink Children's Ambulatory Care Center — New York, New York
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
• Atrium Health Levine Children's Hospital — Charlotte, North Carolina
• Duke Molecular Physiology Institute — Durham, North Carolina
• Nationwide Children's Hospital — Columbus, Ohio
• University of Oklahoma Health Sciences Center (OUHSC) — Oklahoma City, Oklahoma
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
• St. Christopher's Hospital for Children — Philadelphia, Pennsylvania
• Texas Children's Hospital — Houston, Texas
• UT Health - John P. and Kathrine G. McGovern Medical School — Houston, Texas
• Seattle Children's Hospital — Seattle, Washington
• Uniklinik Köln, Klinik und Poliklinik für Kinder- und Jugendmedizin — Cologne,
• Universitätsklinikum Hamburg-Eppendorf — Hamburg,

📞 Contact the Study Coordinator

Phone: (877) 659-5518

Email: medinfo@travere.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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.

More studies in Focal Segmental Glomerulosclerosis

• An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases — Bethesda, Maryland
• Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children — Loma Linda, California
• Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System — Loma Linda, California
• A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS) — Chula Vista, California
• Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis and Minimal Change Disease — Ann Arbor, Michigan

Explore by condition: All Focal Segmental Glomerulosclerosis clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.