Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients

Proteinuria Clinical Trial

Official title:

Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02057523
• Other study ID #: 2013-0764
• Status: Terminated
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Proteinuria
• Transplant Glomerulopathy

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