National Institute of Allergy and Infectious Diseases (NIAID)
The purpose of this study is to evaluate the safety of carfilzomib and belatacept, administered with steroids and maintenance immunosuppression, in kidney transplant recipients with donor-specific antibody (DSA)-associated graft injury. Participants will be followed for 52 weeks after starting investigational therapy, including protocol biopsies at 3 months and 12 months after start of investigational therapy. The study will also assess changes in immune cell responses, blood and urine biomarkers, and biopsy-based pathomic features associated with antibody-mediated graft injury.
This is a prospective, multicenter, open-label study evaluating the safety of carfilzomib and belatacept in kidney transplant recipients with donor-specific antibody-associated graft injury. Twenty-five participants will receive steroid pulse/taper, carfilzomib, belatacept, tacrolimus, mycophenolate, and prednisone according to protocol-defined dosing and maintenance immunosuppression. Participants will be followed for 12 months after initiation of investigational therapy, with protocol biopsies performed at 3 months and 12 months after start of investigational therapy. Participants who discon…
Inclusion Criteria: 1. Able to understand and agree to participate in the study. 2. Have received a kidney transplant from a living or deceased donor (including re-transplants). 3. Men and women must agree to use birth control during the study and for 3 months after the last dose of study drugs, or be surgically sterile or post-menopausal. 4. Heart function must be good enough (LVEF of at least 40%) without severe heart issues or high blood pressure in the lungs. 5. Must have been previously exposed to the Epstein-Barr Virus (EBV). 6. Diagnosed with specific types of kidney transplant rejecti…
Administered by intravenous infusion over 60 minutes.
Administered by intravenous infusion over 30 minutes.