Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar
Purpose
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).
Condition
- Transplant Glomerulopathy
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- 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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Acthar |
The study cohort. In this cohort Acthar gel will be administered to the enrolled patient with chrnic AMR. |
|
More Details
- Status
- Terminated
- Sponsor
- University of Maryland, Baltimore
Study Contact
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.