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

University of Maryland Baltimore (UMB)

Status and phase

Terminated

Phase 4

Conditions

Transplant Glomerulopathy

Treatments

Drug: Acthar gel

Study type

Interventional

Funder types

Other

Identifiers

NCT02546492

HP-00063872

Details and patient eligibility

About

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).

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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