Safety and Efficacy of Acthar Gel in an Outpatient Dialysis Population

• Status: Terminated
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Youngstown State University
• Treatments: Adrenocorticotropic Hormone

Criteria

Inclusion Criteria:

• Inclusion criteria will be individuals requiring dialysis for treatment of ESRD who have had poor response to immunosuppressive strategies.

• Non-Diabetic

• Adults age 18-80

Exclusion Criteria:

• receiving hemodialysis for > 5 years

• diabetic, less than 18 years of age

• are pregnant

• have a history of cancer in the last 5 years

• have an active infection

• have recently had a myocardial infarction (within 6 weeks)

• have malignant arrhythmias, unstable angina, uncontrolled hypertension (SBP> 180 and/or DBP > 105)

• recent hospitalization (< 30 days),

• ocular disease,

• accelerated osteoporosis,

• gastrointestinal diseases (ulcerative colitis, diverticulitis, myasthenia gravis)

• any disorder that may be exacerbated by short periods of activity.

• cognitive dysfunction

• neurological deficits leading to limited ambulation.