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

Phase 4TerminatedNCT02546492

University of Maryland, Baltimore6 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Transplant Glomerulopathy

Interventions

Acthar gelDRUG

Administration of the study drug in addition to the current maintenance immunosuppressive agents

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Alabama School of Medicine, Alabama Transplant Center

Birmingham, Alabama, United States

Unniversity of Maryland Medical Center

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Safety (Serious Adverse Events)

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.

Time frame: 12 months

Secondary Outcomes

Efficacy Outcome

composite of graft loss, death, decrease in eGFR\>10%, and increase in proteinuria

Time frame: 1 year

Data from ClinicalTrials.gov

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