Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by University of Illinois at Chicago
Sponsor:
Collaborator:
Questcor Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Sanjeev Akkina, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT02057523
First received: February 5, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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
Proteinuria
Transplant Glomerulopathy
Drug: Acthar
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 25% Reduction in the MDRD eGFR [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2015
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 80mg 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 80mg 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 40mg 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT02057523

Contacts
Contact: Sanjeev Akkina, MD 312-996-8075 sakkina@uic.edu
Contact: Maya Campara, PharmD 312-996-0897 ext 1 mcampa4@uic.edu

Locations
United States, Illinois
University of Illinois at Chicago Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Sanjeev Akkina, MD    312-996-8075    sakkina@uic.edu   
Contact: Maya Campara, PharmD    312-996-0897    mcampa4@uic.edu   
Principal Investigator: Sanjeev Akkina, MD         
Sponsors and Collaborators
University of Illinois at Chicago
Questcor Pharmaceuticals, Inc.
Investigators
Principal Investigator: Sanjeev Akkina, MD University of Illinois at Chicago
  More Information

No publications provided

Responsible Party: Sanjeev Akkina, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02057523     History of Changes
Other Study ID Numbers: 2013-0764
Study First Received: February 5, 2014
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Proteinuria
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Adrenocorticotropic Hormone
Beta-Endorphin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014