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Trial record 1 of 1 for:    NCT02486744
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Safety and Efficacy of Acthar Gel in an Outpatient Dialysis Population

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ClinicalTrials.gov Identifier: NCT02486744
Recruitment Status : Terminated (Recruitment challenges and unforseen costs to continue)
First Posted : July 1, 2015
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Youngstown State University

Brief 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Drug: Acthar Gel Phase 1

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Acthar Gel in an Outpatient Dialysis Population
Study Start Date : March 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 80 Units of Acthar
Subjects assigned by random assignment to receive 80 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
Other Name: repository corticotropin injection

Active Comparator: 40 Units of Acthar
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
Other Name: repository corticotropin injection




Primary Outcome Measures :
  1. Renal Function [ Time Frame: 6 months ]
    Maintain or improve renal function [Creatinine clearance and Proteinuria] by ≥ 20% , as measured by eGFR or 24 hour urine study.


Secondary Outcome Measures :
  1. Hyperparathyroidism [ Time Frame: 6 months ]
    Change in serum parathyroid hormone levels

  2. Anemia [ Time Frame: 6 months ]
    Change in hemoglobin levels

  3. Inflammatory blood markers [ Time Frame: 6 months ]
    Change in serum C-Reactive Protein and Creatine Kinase

  4. Vitamin D uptake [ Time Frame: 6 months ]
    Change in Vitamin D dosing requirements

  5. Hypercalcemia [ Time Frame: 6 months ]
    Change in serum calcium levels

  6. Phosphate [ Time Frame: 6 months ]
    Change in serum phosphate levels

  7. Total Iron Binding Capacity [ Time Frame: 6 months ]
    Change in Total Iron Binding Capacity in serum

  8. Epogen Dose [ Time Frame: 6 months ]
    Change in epogen dosing requirements

  9. Fall risk [ Time Frame: 6 months ]
    Timed Up and Go Test will improve

  10. Walking endurance [ Time Frame: 6 months ]
    2 minute walk distance

  11. Gait speed [ Time Frame: 6 months ]
    10 meter gait speed test

  12. Mobility disablement risk [ Time Frame: 6 months ]
    Short Performance Physical Battery

  13. Habitual Physical Activity [ Time Frame: 6 months ]
    Physical Activity Scale for the Elderly

  14. Calf Strength [ Time Frame: 6 months ]
    Heel Rise Test

  15. Quality of life [ Time Frame: 6 months ]
    Medical Outcome Study Short Form 36

  16. Fear of Falling [ Time Frame: 6 months ]
    ABC Scale [Activities-specific Balance Confidence Scale-Powell]. Scores to be above 67.

  17. Self- Report Physical Activity [ Time Frame: 6 months ]
    RAPA [Rapid Assessment of Physical Activity-Univ of Washington]

  18. Nutritional Status [ Time Frame: 6 months ]
    Body Mass Index

  19. Lean body mass [ Time Frame: 6 months ]
    Body Composition examination using Noori (2012) regression equation for lean body mass.

  20. Caloric intake [ Time Frame: 6 months ]
    Food Frequency Questionnaire (indicator of habitual intake)

  21. Strength [ Time Frame: 6 months ]
    Muscle force measures in 8 muscle groups

  22. Nutritional Indices [ Time Frame: 6 months ]
    Pre-Albumin



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486744


Locations
United States, Ohio
Center for Dialysis Care 3695 Stutz Drive
Canfield, Ohio, United States, 44406
Sponsors and Collaborators
Youngstown State University
Investigators
Principal Investigator: Erdal Sarac, MD Renal Group

Responsible Party: Youngstown State University
ClinicalTrials.gov Identifier: NCT02486744     History of Changes
Other Study ID Numbers: 014-2015
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Youngstown State University:
Acthar
Dialysis
Kidney
Non-Diabetic

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs