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Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar (TGActhar)

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ClinicalTrials.gov Identifier: NCT02546492
Recruitment Status : Recruiting
First Posted : September 11, 2015
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Abdoleza Haririan, University of Maryland

Brief Summary:
This is an open label safety and feasibility trial using Acthar® in addition to the investigators center-specific standard therapy, which could include increase in maintenance immunosuppression, high dose IVIG (2 g/Kg), and/or Rituximab, in patients with CAMR.

Condition or disease Intervention/treatment Phase
Transplant Glomerulopathy Drug: Acthar gel Phase 4

Detailed Description:

Subjects will receive Acthar® 40 units twice a week subcutaneously for 2 weeks. If the drug is well tolerated the dose will be increased to 80 units twice a week for another 22 weeks. The patients will be maintained on their center-specific standard maintenance regimen, typically consisting of Tacrolimus, mycephenolate mofetil/Sodium, and prednisone.

After screening for the inclusion/exclusion criteria, the patients will be consented and enrolled in the study. The initial visit and subsequent study-related visits at 4, 8, 12, 24, 36 and 52 weeks will include routine evaluation and physical examination and laboratory studies including CBC, electrolyte panel, eGFR, albumin, liver enzymes, and CNI/sirulimus drug level, according to the center's standard of care. DSA will be tested at week 24, and 52 and patients will undergo a biopsy at week 52, as a part of the investigators standard of care. The biopsies will be evaluated by light and electron microscopy using standard histological Banff criteria, and staining for CD68.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar
Actual Study Start Date : August 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acthar
The study cohort. In this cohort Acthar gel will be administered to the enrolled patient with chrnic AMR.
Drug: Acthar gel
Administration of the study drug in addition to the current maintenance immunosuppressive agents
Other Name: ACTH




Primary Outcome Measures :
  1. Efficacy end point (Composite of graft loss, death, decrease in eGFR>10%, and increase in proteinuria) [ Time Frame: 12 months ]
    Composite of graft loss, death, decrease in eGFR>10%, and increase in proteinuria (defined as >50% increase if baseline proteinuria <2 g, or persistence of proteinuria >2 g otherwise)


Secondary Outcome Measures :
  1. Safety (Serious adverse events) [ Time Frame: 12 months ]
    Serious adverse events

  2. Graft loss (Kidney allograft failure or death) [ Time Frame: 12 months ]
    Kidney allograft failure or death

  3. Graft function (>10% decrease in eGFR) [ Time Frame: 12 months ]
    >10% decrease in eGFR

  4. Proteniuria (Increase in proteinuria >50% if baseline proteinuria<2 g, or persistence of proteinuria >2 g otherwise) [ Time Frame: 12 months ]
    Increase in proteinuria >50% if baseline proteinuria<2 g, or persistence of proteinuria >2 g otherwise



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

Inclusion Criteria:

  • Age >18 years
  • Morphologic diagnosis of CAMR, by light &/or electron microscopy any time after transplantation
  • Current or previously documented donor-specific antibody (DSA) and/or focal or diffuse peritubular capillary C4d staining by immunohistochemistry
  • eGFR>25 ml/min

Exclusion Criteria:

  • Diagnosis of malignancy within a year prior to enrollment (except cured cutaneous basal cell or squamous cell carcinoma).
  • Lack of evidence of antibody involvement
  • Pregnancy, lactation, or refusal to use birth control in women of child bearing potential
  • Active infection, or history of HIV
  • History of liver or thoracic transplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546492


Contacts
Contact: Abdolreza Haririan, MD, MPH 410-328-5720 ahariria@medicine.umaryland.edu
Contact: Matthew Weir, MD 410-328-5720 mweir@medicine.umaryland.edu

Locations
United States, Alabama
University of Alabama School of Medicine, Alabama Transplant Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Roslyn B Mannon, MD    205-934-7220    rmannon@uab.edu   
Contact: Liz Hermon    205-996-9632      
United States, Maryland
Unniversity of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Lalitha Anandagoda, MPH    410-328-5720    laanandagoda@som.umaryland.edu   
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Abdolreza Haririan, MD, MPH University of Maryland

Responsible Party: Abdoleza Haririan, Medical director, Kidney and Pancreas Transplant Program, University of Maryland
ClinicalTrials.gov Identifier: NCT02546492     History of Changes
Other Study ID Numbers: HP-00063872
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Antibodies
Adrenocorticotropic Hormone
Immunologic Factors
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists