A Phase 1 interventional study of Acthar Gel in End Stage Renal Disease, sponsored by Youngstown State University. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-02-10.
Sponsored by Youngstown State University · Phase 1, Interventional, and Treatment
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.
Recent reports demonstrated Acthar gel is effective to induce remission of proteinuria in the Nephrotic Syndrome patients (Bomback 2011, 2012). There are limited published reports documenting the clinical response (creatinine, proteinuria, serum albumin and cholesterol) to ACTHAR therapy in a non-diabetic hemodialysis population. In addition to renal dysfunction and high risk for mortality, individuals who receive dialysis also have decreased strength, low exercise capacity, poor physical functioning, and a low quality of life (Edgell 1996, Johansen, 2001). Strength deficits are well documented in those with End Stage Renal Disease [ESRD] (Cheema 2010, Yoda 2012). There are several reports documenting an association between strength and gait deficits and other measures of physical performance in persons with ESRD (Bohannon 1994, Fitts 1997, Segura-Orti 2011). It is well known that measures of physical performance may predict risk for fall and hospitalization in older individuals (Guralnik JM, 2000).
Deficits to physical performance may be further compounded by poor nutritional status. Persons with chronic renal disease, particularly in the context of hemodialysis or chronic renal replacement therapy, are often malnourished and/or are affected by abnormal micronutrient status (McMahon 2012). Furthermore, previous studies have shown that more than a third of acute-care, nephrology-related admissions are characterized by malnutrition (Lim 2012), and that it affects from 23% - 76% of all patients receiving hemodialysis (including outpatients)(Blumenkrantz 1980, Ikizler 1996, Pecoits-Filho 2002).
Decreased functional status and concomitant malnutrition contribute to increased hospital readmissions, prolonged length of stay (and inevitably, increased medical costs), and increased morbidity and mortality patients (Isabel 2003, Lim 2012). Given the high prevalence of these characteristics in persons with renal disease, it is important to prioritize identification of novel and effective means by which to sustain and improve the functional capability of these patients, and to maintain their nutritional status and attenuate malnutrition.
To date, there are no reports of the impact of Acthar gel therapy on renal function, strength, physical performance, nutritional status and quality of life in NDHD patients. This study will determine if Acthar gel therapy will maintain or improve overall kidney function as measured with 24 hour urine study at baseline and at the end of study period. In addition this study will determine if Acthar gel therapy will improve nutritional, physical and biochemical status in an outpatient non-diabetic hemodialysis population.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 9 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Youngstown State University is the lead sponsor of 29 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Subjects assigned by random assignment to receive 80 Units of Acthar Gel 2x weekly for 6 months
Drug: Acthar Gel
Subjects assigned by random assignment to receive 40 Units of Acthar Gel 2x weekly for 6 months
Drug: Acthar Gel
Subjects will be given an injection subcutaneously 2x week for 6 months. Dosing will be randomly assigned as either 80 U or 40 U
Also known as: repository corticotropin injection
Renal Function
Maintain or improve renal function \[Creatinine clearance and Proteinuria\] by ≥ 20% , as measured by eGFR or 24 hour urine study.
Time frame: 6 months
Hyperparathyroidism
Change in serum parathyroid hormone levels
Time frame: 6 months
Anemia
Change in hemoglobin levels
Time frame: 6 months
Inflammatory blood markers
Change in serum C-Reactive Protein and Creatine Kinase
Time frame: 6 months
Vitamin D uptake
Change in Vitamin D dosing requirements
Time frame: 6 months
Hypercalcemia
Change in serum calcium levels
Time frame: 6 months
Phosphate
Change in serum phosphate levels
Time frame: 6 months
Total Iron Binding Capacity
Change in Total Iron Binding Capacity in serum
Time frame: 6 months
Epogen Dose
Change in epogen dosing requirements
Time frame: 6 months
Fall risk
Timed Up and Go Test will improve
Time frame: 6 months
Walking endurance
2 minute walk distance
Time frame: 6 months
Gait speed
10 meter gait speed test
Time frame: 6 months
Mobility disablement risk
Short Performance Physical Battery
Time frame: 6 months
Habitual Physical Activity
Physical Activity Scale for the Elderly
Time frame: 6 months
Calf Strength
Heel Rise Test
Time frame: 6 months
Quality of life
Medical Outcome Study Short Form 36
Time frame: 6 months
Fear of Falling
ABC Scale \[Activities-specific Balance Confidence Scale-Powell\]. Scores to be above 67.
Time frame: 6 months
Self- Report Physical Activity
RAPA \[Rapid Assessment of Physical Activity-Univ of Washington\]
Time frame: 6 months
Nutritional Status
Body Mass Index
Time frame: 6 months
Lean body mass
Body Composition examination using Noori (2012) regression equation for lean body mass.
Time frame: 6 months
Caloric intake
Food Frequency Questionnaire (indicator of habitual intake)
Time frame: 6 months
Strength
Muscle force measures in 8 muscle groups
Time frame: 6 months
Nutritional Indices
Pre-Albumin
Time frame: 6 months
Plan to share: No
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This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Youngstown State University