Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
EPPIK (IgAN, IgAV, Alport Syndrome)
The EPPIK Clinical Study for Children with IgAN, IgAV, and Alport Syndrome
The EPPIK study will evaluate the investigational drug, sparsentan, for the treatment of selected rare kidney diseases. The investigational approach is to lower proteinuria levels with sparsentan and slow the loss of kidney function in children ages 2-17 with enrollment currently open to patients aged 2 to 7 years. Indications include: • IgA nephropathy (IgAN), also known as Berger’s disease • IgA vasculitis (IgAV), also known as Henoch-Schönlein purpura • Alport syndrome (AS).
See also the EPPIK Clinical Study for Children with FSGS and MCD.
Trial Physician / Study Coordinator
Amy Hanson
Email Phone 612-626-4424Site Name
University of Minnesota
Department of Pediatrics, Riverside Professional Building, Suite 535, 606 24th Avenue South, Minneapolis, MN 55454
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
EPPIK (IgAN, IgAV, Alport Syndrome)
The EPPIK Clinical Study for Children with IgAN, IgAV, and Alport Syndrome
The EPPIK study will evaluate the investigational drug, sparsentan, for the treatment of selected rare kidney diseases. The investigational approach is to lower proteinuria levels with sparsentan and slow the loss of kidney function in children ages 2-17 with enrollment currently open to patients aged 2 to 7 years. Indications include: • IgA nephropathy (IgAN), also known as Berger’s disease • IgA vasculitis (IgAV), also known as Henoch-Schönlein purpura • Alport syndrome (AS).
See also the EPPIK Clinical Study for Children with FSGS and MCD.
Eligibility Criteria
Patient Population
For children ages 2-17 with:
• IgA nephropathy (IgAN), also known as Berger’s disease
• IgA vasculitis (IgAV), also known as Henoch-Schönlein purpura
• Alport syndrome (AS)
Age
2 — 17
History of transplant allowed?
No
History of dialysis allowed?
No
eGFR
30 — > 60
UPCR
1.0 or Less — 3.0 or Above
Permitted medication history
Ace Inhibitors/ARB, Prednisone (Steroids), Acthar, Cellcept (AKA Mycophenolate), Prograf (AKA Tacrolimus), Other, None
Patient should be
Treatment Resistant, Steroid Dependent
About the Drug
What is involved for the patient
Patients will participate for about 2 years and 3 months and will receive sparsentan.
Estimated End Date
To be determined
About the Trial
Study Goal
The goals of the study are to evaluate the safety and effectiveness of sparsentan on children with FSGS, MCD, IgAN, IgAV and Alport syndrome.
About the drug or intervention
Participants receive sparsentan, the investigational drug, taken as a liquid by mouth.