drugset / Trial / NCT00805753

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

NCT00805753

Phase 1 Completed 20 enrolled Mayo Clinic Mallinckrodt · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-01
Primary completion
2013-09
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acthar Peptide 40 iu Subcutaneous
Comparator Acthar Peptide 80 iu Subcutaneous