Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients

NCT02057523 | Terminated Phase 4 Results

• 1 other identifier: 2013-0764
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Proteinuria; Transplant Glomerulopathy

Outcome Measures

Primary Outcomes (1)

• 50% Reduction in Proteinuria or Proteinuria < 150mg/Day

  6 months

Secondary Outcomes (1)

• 25% Improvement in the MDRD eGFR

  6 months

Study Arms (1)

Acthar

EXPERIMENTAL

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

Drug: Acthar

Interventions

Acthar DRUG

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.

Also known as: Repository Corticotropin Hormone, Acthar Gel, Adrenocorticotropic Hormone

Acthar

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diabetes

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Mallinckrodt: collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Proteinuria

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Sanjeev Akkina
• Organization: Loyola University Medical Center

sanjeev.akkina@lumc.edu

7082166389

Study Officials

• Sanjeev Akkina, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 7, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 4, 2020
• Results First Posted: September 4, 2020

Record last verified: 2020-08

Locations

US (1)