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A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK)

Recruiting

Currently, there are no approved treatment options for pediatric subjects with proteinuric kidney conditions. The study will look at the safety, efficacy, and pharmacokinetic (PK)trial in children ≥1 to <18 years treated for up to 108 weeks with the drug sparsentan.

I'm interested

Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Child 1 to 18 years old
• Diagnosed by biopsy with specific types of glomerular disease & protein in the urine
• Blood pressure is within normal range for age
• Maintained on a stable dose of immunosuppressive medications
Exclusion Criteria:

• Weight less than 7.3 kg 16 pounds) at screening.
• Disease due to to viral infections, drug toxicities, or cancer.
• Kidney function is below the minimum required

Drug: Sparsentan, Drug: Sparsentan, Drug: Sparsentan

Children's Health, Kidney, Prostate & Urinary, Rare Diseases

Alport Syndrome, Glomerulosclerosis, IgA Vasculitis, Immunoglobulin A Nephropathy

Anael Kuperwajs Cohen - kuper029@umn.edu
Michelle Rheault
PHASE2
SITE00001245
33702
See this study on ClinicalTrials.gov

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