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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)

Status: 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

Age: Up to 18 years old
Healthy Volunteers:
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
Interventions:

Drug: Sparsentan, Drug: Sparsentan, Drug: Sparsentan

Conditions:

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

Keywords:

Alport Syndrome, Glomerulosclerosis, IgA Vasculitis, Immunoglobulin A Nephropathy

Contact(s): Anael Kuperwajs Cohen - kuper029@umn.edu
Principal Investigator: Michelle Rheault
Phase: PHASE2
IRB Number: SITE00001245
System ID: 33702
See this study on ClinicalTrials.gov

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