Clincosm LogoSign in Get a demo

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

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Terminated
CT.gov ID
NCT02546492
Collaborator
University of Alabama at Birmingham (Other)
6
Enrollment
2
Locations
1
Arm
57.8
Actual Duration (Months)
3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
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 :
Aug 1, 2016
Actual Primary Completion Date :
May 27, 2021
Actual Study Completion Date :
May 27, 2021

Arms and Interventions

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 Names:
  • ACTH

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy end point (Composite of graft loss, death, decrease in eGFR>10%, and increase in proteinuria) [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) [12 months]

      Serious adverse events

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

      Kidney allograft failure or death

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

      >10% decrease in eGFR

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

      Increase in proteinuria >50% if baseline proteinuria<2 g, or persistence of proteinuria >2 g otherwise

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama School of Medicine, Alabama Transplant Center Birmingham Alabama United States 35294
    2 Unniversity of Maryland Medical Center Baltimore Maryland United States 21201

    Sponsors and Collaborators

    • University of Maryland, Baltimore
    • University of Alabama at Birmingham

    Investigators

    • Principal Investigator: Abdolreza Haririan, MD, MPH, University of Maryland, Baltimore

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abdoleza Haririan, Medical director, Kidney and Pancreas Transplant Program, University of Maryland, Baltimore
    ClinicalTrials.gov Identifier:
    NCT02546492
    Other Study ID Numbers:
    • HP-00063872
    First Posted:
    Sep 11, 2015
    Last Update Posted:
    Feb 10, 2022
    Last Verified:
    Jan 1, 2022
    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

    Study Results

    No Results Posted as of Feb 10, 2022