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

Phase 4

Terminated

• Conditions: Transplant Glomerulopathy
• Interventions: Drug: Acthar gel

• Registration Number: NCT02546492
• Lead Sponsor: University of Maryland, Baltimore

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 (intravenous immunoglobulin) (2 g/Kg), and/or Rituximab, in patients with chronic antibody-mediated rejection (CAMR).

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 (complete blood count), electrolyte panel, eGFR, albumin, liver enzymes, and Calcineurin inhibitor (CNI)/sirolimus drug level, according to the center's standard of care. Donor-specific antibody (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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-11
• Study Start: 2016-08
• Primary Completion: 2021-05-27
• Study Completion: 2021-05-27
• Results First Submitted: 2022-07-12
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-03
• Last Update Submitted: 2022-10-03
• Results First Posted: 2022-10-06
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acthar	Acthar gel	The study cohort. In this cohort Acthar gel will be administered to the enrolled patient with chrnic AMR.

Primary Outcome Measures

Name	Time	Method
Safety (Serious Adverse Events)	12 months	Participants will be monitored for Serious Adverse Events, as follows (as described in ClinicalTrials.gov) Death, Life-threatening events, Hospitalization (initial or prolonged), Disability and events that requires intervention to prevent permanent impairment or damage.; Other (non serious) events which were anticipated or unanticipated (as described in ClinicaTrials.gov) will be monitored.; ASSESSMENT: The subjects will be assessed at regular intervals through a questionnaire for Acthar related events, physician evaluation at clinical visits, and self reporting.

Secondary Outcome Measures

Name	Time	Method
Efficacy Outcome	1 year	composite of graft loss, death, decrease in eGFR\>10%, and increase in proteinuria

Trial Locations

Locations (2)

Unniversity of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

University of Alabama School of Medicine, Alabama Transplant Center; 🇺🇸 Birmingham, Alabama, United States