Try our beta test site

Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University of Illinois at Chicago.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Sanjeev Akkina, University of Illinois at Chicago Identifier:
First received: February 5, 2014
Last updated: December 3, 2014
Last verified: December 2014
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.

Condition Intervention Phase
Transplant Glomerulopathy
Drug: Acthar
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients

Resource links provided by NLM:

Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • 50% Reduction in Proteinuria or Proteinuria < 150mg/day [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 25% Improvement in the MDRD eGFR [ Time Frame: 6 months ]

Estimated Enrollment: 10
Study Start Date: September 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acthar
Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months.
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.
Other Names:
  • Repository Corticotropin Hormone
  • Acthar Gel
  • Adrenocorticotropic Hormone


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02057523

United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Principal Investigator: Sanjeev Akkina, MD University of Illinois at Chicago
  More Information

Responsible Party: Sanjeev Akkina, Assistant Professor, University of Illinois at Chicago Identifier: NCT02057523     History of Changes
Other Study ID Numbers: 2013-0764 
Study First Received: February 5, 2014
Last Updated: December 3, 2014

Additional relevant MeSH terms:
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Adrenocorticotropic Hormone
Melanocyte-Stimulating Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on February 17, 2017