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Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02546492
Study type Interventional
Source University of Maryland, Baltimore
Contact
Status Terminated
Phase Phase 4
Start date August 2016
Completion date May 27, 2021

See also
  Status Clinical Trial Phase
Terminated NCT02057523 - Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients Phase 4
Active, not recruiting NCT03380962 - Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant Phase 1/Phase 2
Completed NCT03380377 - Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant Phase 1/Phase 2