Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients

Phase 4

Terminated

• Conditions: Proteinuria; Transplant Glomerulopathy
• Interventions: Drug: Acthar

• Registration Number: NCT02057523
• Lead Sponsor: University of Illinois at Chicago

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-05
• Study First Posted: 2014-02-07
• Study Start: 2014-09
• Primary Completion: 2015-03
• Study Completion: 2015-09
• Status Verified: 2020-08
• Results First Submitted: 2020-08-20
• Results First Submitted QC: 2020-08-20
• Last Update Submitted: 2020-08-20
• Results First Posted: 2020-09-04
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acthar	Acthar	Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months.

Primary Outcome Measures

Name	Time	Method
50% Reduction in Proteinuria or Proteinuria < 150mg/Day	6 months

Secondary Outcome Measures

Name	Time	Method
25% Improvement in the MDRD eGFR	6 months

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States