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Clinical Trial Details

Trial ID: L0865
Source ID: NCT02486744
Associated Drug: Acthar Gel
Title: Safety and Efficacy of Acthar Gel in an Outpatient Dialysis Population
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: End Stage Renal Disease
Interventions: DRUG: Acthar Gel
Outcome Measures: Primary: Renal Function, Maintain or improve renal function \[Creatinine clearance and Proteinuria\] by ≥ 20% , as measured by eGFR or 24 hour urine study., 6 months | Secondary: Hyperparathyroidism, Change in serum parathyroid hormone levels, 6 months|Anemia, Change in hemoglobin levels, 6 months|Inflammatory blood markers, Change in serum C-Reactive Protein and Creatine Kinase, 6 months|Vitamin D uptake, Change in Vitamin D dosing requirements, 6 months|Hypercalcemia, Change in serum calcium levels, 6 months|Phosphate, Change in serum phosphate levels, 6 months|Total Iron Binding Capacity, Change in Total Iron Binding Capacity in serum, 6 months|Epogen Dose, Change in epogen dosing requirements, 6 months|Fall risk, Timed Up and Go Test will improve, 6 months|Walking endurance, 2 minute walk distance, 6 months|Gait speed, 10 meter gait speed test, 6 months|Mobility disablement risk, Short Performance Physical Battery, 6 months|Habitual Physical Activity, Physical Activity Scale for the Elderly, 6 months|Calf Strength, Heel Rise Test, 6 months|Quality of life, Medical Outcome Study Short Form 36, 6 months|Fear of Falling, ABC Scale \[Activities-specific Balance Confidence Scale-Powell\]. Scores to be above 67., 6 months|Self- Report Physical Activity, RAPA \[Rapid Assessment of Physical Activity-Univ of Washington\], 6 months|Nutritional Status, Body Mass Index, 6 months|Lean body mass, Body Composition examination using Noori (2012) regression equation for lean body mass., 6 months|Caloric intake, Food Frequency Questionnaire (indicator of habitual intake), 6 months|Strength, Muscle force measures in 8 muscle groups, 6 months|Nutritional Indices, Pre-Albumin, 6 months
Sponsor/Collaborators: Sponsor: Youngstown State University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 9
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-03
Completion Date: 2016-07
Results First Posted:
Last Update Posted: 2017-02-10
Locations: Center for Dialysis Care 3695 Stutz Drive, Canfield, Ohio, 44406, United States
URL: https://clinicaltrials.gov/show/NCT02486744