NCT02633046

Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria

Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A Prospective Study of Acthar (PODOCYTE)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Mallinckrodt ARD LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Focal segmental glomerulosclerosis (FSGS) is a condition that harms the kidney "filters" that remove waste from the blood. Proteins are supposed to stay in the blood. Damaged "filters" let protein get into the kidney. FSGS is a serious condition that can lead to kidney failure. The only treatment for kidney failure is dialysis or kidney transplant. Proteinuria means too much protein came through the kidneys into the urine. If the doctor cannot figure out what is causing the problem, it is primary (idiopathic) FSGS. This kind of FSGS is very hard to treat. This study will test Acthar in patients with this condition who have not responded to other treatments. It primarily investigates how well the therapy is tolerated by the patients and how well they respond to this treatment.

Conditions

• Idiopathic Focal Segmental Glomerulosclerosis

Interventions

Type	Name	Description
DRUG	Acthar Gel	Acthar Gel 80 U/mL solution for subcutaneous injection

Timeline

• Start date: 2016-10-10
• Primary completion: 2020-08-27
• Completion: 2020-08-27
• First posted: 2015-12-17
• Last updated: 2021-08-04
• Results posted: 2021-08-03

Locations

47 sites across 7 countries: United States, Argentina, Australia, Chile, Mexico, Peru, Turkey (Türkiye)