Safety and Efficacy of Acthar Gel in an Outpatient Dialysis Population

End Stage Renal Disease Clinical Trial

Official title:

Safety and Efficacy of Acthar Gel in an Outpatient Dialysis Population

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02486744
• Other study ID #: 014-2015
• Status: Terminated
• Phase: Phase 1
• First received: June 8, 2015
• Last updated: February 8, 2017
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: February 2017
• Source: Youngstown State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Center for Dialysis Care 3695 Stutz Drive	Canfield	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Youngstown State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Secondary	Anemia	Change in hemoglobin levels	6 months
Secondary	Inflammatory blood markers	Change in serum C-Reactive Protein and Creatine Kinase	6 months
Secondary	Vitamin D uptake	Change in Vitamin D dosing requirements	6 months
Secondary	Hypercalcemia	Change in serum calcium levels	6 months
Secondary	Phosphate	Change in serum phosphate levels	6 months
Secondary	Total Iron Binding Capacity	Change in Total Iron Binding Capacity in serum	6 months
Secondary	Epogen Dose	Change in epogen dosing requirements	6 months
Secondary	Fall risk	Timed Up and Go Test will improve	6 months
Secondary	Walking endurance	2 minute walk distance	6 months
Secondary	Gait speed	10 meter gait speed test	6 months
Secondary	Mobility disablement risk	Short Performance Physical Battery	6 months
Secondary	Habitual Physical Activity	Physical Activity Scale for the Elderly	6 months
Secondary	Calf Strength	Heel Rise Test	6 months
Secondary	Quality of life	Medical Outcome Study Short Form 36	6 months
Secondary	Fear of Falling	ABC Scale [Activities-specific Balance Confidence Scale-Powell]. Scores to be above 67.	6 months
Secondary	Self- Report Physical Activity	RAPA [Rapid Assessment of Physical Activity-Univ of Washington]	6 months
Secondary	Nutritional Status	Body Mass Index	6 months
Secondary	Lean body mass	Body Composition examination using Noori (2012) regression equation for lean body mass.	6 months
Secondary	Caloric intake	Food Frequency Questionnaire (indicator of habitual intake)	6 months
Secondary	Strength	Muscle force measures in 8 muscle groups	6 months
Secondary	Nutritional Indices	Pre-Albumin	6 months