Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients

University of Illinois

Status and phase: Terminated; Phase 4

Conditions: Transplant Glomerulopathy; Proteinuria

Treatments: Drug: Acthar

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02057523

2013-0764

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Acthar

Experimental group

Description:

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

Treatment:

Drug: Acthar