Back to resultsActhar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients
Primary Purpose
Proteinuria, Transplant Glomerulopathy
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acthar
Sponsored by
About this trial
This is an interventional treatment trial for Proteinuria
Eligibility Criteria
Inclusion Criteria:
- Kidney transplant recipients with confirmed transplant glomerulopathy on kidney biopsy.
- Failed standard therapy (>25% reduction in proteinuria) including maximum use of an ACE inhibitor, ARB, or aldosterone blocker with a goal blood pressure less than 130/80 and optimization of their immunosuppression
Exclusion Criteria:
- Diabetes
Sites / Locations
- University of Illinois at Chicago
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acthar
Arm Description
Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months.
Outcomes
Primary Outcome Measures
50% Reduction in Proteinuria or Proteinuria < 150mg/Day
Secondary Outcome Measures
25% Improvement in the MDRD eGFR
Full Information
NCT ID
NCT02057523
First Posted
February 5, 2014
Last Updated
August 20, 2020
Sponsor
University of Illinois at Chicago
Collaborators
Mallinckrodt
1. Study Identification
Unique Protocol Identification Number
NCT02057523
Brief Title
Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients
Official Title
Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Unable to enroll patients, no longer at institution.
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Mallinckrodt
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to evaluate the benefit of ACTH (Acthar) in reducing proteinuria associated with transplant glomerulopathy in non-diabetic kidney transplant recipients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proteinuria, Transplant Glomerulopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acthar
Arm Type
Experimental
Arm Description
Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months.
Intervention Type
Drug
Intervention Name(s)
Acthar
Other Intervention Name(s)
Repository Corticotropin Hormone, Acthar Gel, Adrenocorticotropic Hormone
Intervention Description
Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.
Primary Outcome Measure Information:
Title
50% Reduction in Proteinuria or Proteinuria < 150mg/Day
Time Frame
6 months
Secondary Outcome Measure Information:
Title
25% Improvement in the MDRD eGFR
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Kidney transplant recipients with confirmed transplant glomerulopathy on kidney biopsy.
Failed standard therapy (>25% reduction in proteinuria) including maximum use of an ACE inhibitor, ARB, or aldosterone blocker with a goal blood pressure less than 130/80 and optimization of their immunosuppression
Exclusion Criteria:
Diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjeev Akkina, MD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients
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