NCT00805753

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Membranous Nephropathy

Interventions

Type	Name	Description
DRUG	ACTH	comparison of different dosages of drug

Timeline

• Start date: 2009-01-01
• Primary completion: 2013-09-01
• Completion: 2014-09-01
• First posted: 2008-12-10
• Last updated: 2014-10-13

Locations

2 sites across 2 countries: United States, Canada