Safety and Efficacy of Acthar Gel in an Outpatient Dialysis Population
Stopped early · Phase 1
Conditions studied: End Stage Renal Disease
In brief
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.
Key facts
- Study ID
- NCT02486744
- Run by
- Youngstown State University
- People needed
- 9
- Starts
- 2015-03-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2017-02-10
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Center for Dialysis Care 3695 Stutz Drive — Canfield, Ohio, United States
Full record on ClinicalTrials.gov
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