Clinical Trial: Dose-Finding Pilot Study of ACTH in Patients With Idiopathic Membranous Nephropathy

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

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

Brief Summary: This pilot study is aimed at demonstrating the effectiveness of ACTH (H.P. Acthar Gel) on the lipid profile and proteinuria in participants with MN. ACTH or adrenocorticotrophin is a hormone produced by the pituitary gland (a gland at the base of your brain) that is involved in stimulating your adrenal glands to secrete a number of steroid products (e.g. cortisol, aldosterone, corticosterone, and others) that are important in keeping you alive. The drug used in this study has been approved by the Food and Drug Administration (FDA) for routine clinical use in the treatment of patients with proteinuria and patients with idiopathic nephrotic syndrome such as idiopathic MN. However, the most adequate dose to use has not been adequately assessed. This is the reason for conducting this research study.

Detailed Summary:
Sponsor: Mayo Clinic

Current Primary Outcome:

  • Change in proteinuria [ Time Frame: baseline, 3 months ]
  • Change in LDL cholesterol, HDL cholesterol, and triglycerides [ Time Frame: baseline, 3 months ]
  • Change in side effects/toxicity [ Time Frame: baseline, 3 months ]


Original Primary Outcome:

  • Change in proteinuria [ Time Frame: 3 months ]
  • Change in LDL cholesterol, HDL cholesterol, and triglycerides [ Time Frame: 3 months ]
  • side effects/toxicity [ Time Frame: 3 months ]


Current Secondary Outcome:

  • Number of subjects with CR or PR [ Time Frame: 3 months ]
  • The effect of maximizing angiotensin II blockade on proteinuria [ Time Frame: 3 months ]


Original Secondary Outcome:

  • CR or PR [ Time Frame: 3 months ]
  • The effect of maximizing angiotensin II blockade on proteinuria [ Time Frame: 3 months ]


Information By: Mayo Clinic

Dates:
Date Received: December 9, 2008
Date Started: January 2009
Date Completion:
Last Updated: October 10, 2014
Last Verified: October 2014