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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Dose-finding Pilot Study of ACTH (Adrenocorticotropic Hormone) on the Proteinuria and Serum Lipoprotein Profile in Patients With Idiopathic Membranous Nephropathy (MN)

Brief 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.

Detailed Summary:
Sponsor: University Health Network, Toronto

Current Primary Outcome: change in proteinuria from baseline to value at 3 months . [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Complete Remission(CR) or Partial Remission (PR) at 3 months [ Time Frame: 3 months ]
  Definition of proteinuric status. UP = urinary protein (g/24h) Complete remission (CR) UP ≤ 0.3 g Partial remission (PR) Reduction in UP of > 50% plus final UP ≤ 3.5 g but >0.3g Non-response (NR) Reduction in UP of < 50%. (includes increase in UP <50%) Progression Proteinuria increases by > 50%
• Adverse effects [ Time Frame: Throughout three months of this study and for nine months follow-up ]
  Patients will be directly questioned every two weeks during the drug exposure and then at monthly intervals during follow-up. In addition a contact number will be provided to the subjects to call if they experience any adverse affect or if they suspect adverse effect at any time between specific visits

Original Secondary Outcome: Same as current

Information By: University Health Network, Toronto

Dates:
Date Received: March 24, 2010
Date Started: February 2010
Date Completion:
Last Updated: May 2, 2017
Last Verified: January 2013