Overview

A Dose Escalation Study of Long-acting ACTH Gel in Membranous Nephropathy

Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
Participant gender:
Summary
Membranous Nephropathy (MN) is an immune-mediated kidney disease that affects the glomerulus or the filter that removes toxins from the blood. Damage to the membrane that separates blood from urine results in loss of protein into the urine (proteinuria) and in some cases loss of kidney function.There is no standard specific treatment for MN. ACTH has a pronounced lipid-lowering effect in healthy individuals, in steroid-treated patients with renal disease and in hemodialysis patients Some studies suggest that prolonged synthetic ACTH therapy may represent an effective therapy in patients with idiopathic MN, more extensive randomized studies with longer follow-up are needed before therapeutic recommendations can be made. We propose to do a pilot study to test the hypothesis that biologic ACTH, a slow-release formulation of corticotropin extracted from porcine pituitary glands (H.P. Acthar gel) will be effective in reducing proteinuria and improving lipid profile in patients with idiopathic MN.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University Health Network, Toronto
Collaborator:
Mallinckrodt
Treatments:
Adrenocorticotropic Hormone
Hormones