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

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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 (2 g/Kg), and/or Rituximab, in patients with CAMR.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborator: University of Alabama at Birmingham
• Treatments: Adrenocorticotropic Hormone; Antibodies

Criteria

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