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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02057523
Other study ID # 2013-0764
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date September 2014
Est. completion date September 2015

Study information

Verified date August 2020
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date September 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Acthar
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.

Locations

Country Name City State
United States University of Illinois at Chicago Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Illinois at Chicago Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 50% Reduction in Proteinuria or Proteinuria < 150mg/Day 6 months
Secondary 25% Improvement in the MDRD eGFR 6 months
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