Safety and Efficacy of Acthar Gel in an Outpatient Dialysis Population

Summary

This will be a prospective observational study of Acthar Gel in Non-Diabetic Hemodialysis \[NDHD\] patients receiving dialysis for ≤ 2 years. The project will aimed at providing proof-of-concept data that 80 U two times \[2x\] week Acthar for 6 months is a safe and effective therapy for NDHD. Effectiveness of lower dose 40 U 2X week will also be determined. Therefore the study will be a repeated measures design (Time x condition) comparison of improvement in renal function, nutritional status, quality of life and physical performance resulting from Acthar therapy.

Timeline

Start

2015-03

Primary completion

2016-07

Completion

2016-07

Drugs

Indications