Safety and Efficacy of Acthar Gel in an Outpatient Dialysis Population

NCT02486744 | Terminated Phase 1

• 1 other identifier: 014-2015
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

Acthar; Dialysis; Kidney; Non-Diabetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Hyperparathyroidism

  6 months

• Anemia

  6 months

• Inflammatory blood markers

  6 months

• Vitamin D uptake

  6 months

• Hypercalcemia

  6 months

Study Arms (2)

80 Units of Acthar

ACTIVE COMPARATOR

Subjects assigned by random assignment to receive 80 Units of Acthar Gel 2x weekly for 6 months

Drug: Acthar Gel

40 Units of Acthar

ACTIVE COMPARATOR

Subjects assigned by random assignment to receive 40 Units of Acthar Gel 2x weekly for 6 months

Drug: Acthar Gel

Interventions

Acthar Gel DRUG

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

40 Units of Acthar; 80 Units of Acthar

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Youngstown State University: lead

Study Sites (1)

Center for Dialysis Care 3695 Stutz Drive

Canfield, Ohio, 44406, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erdal Sarac, MD

  Renal Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: July 1, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 10, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)