Carfilzomib and Belatacept for Desensitization

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

December 28, 2021

Primary Completion Date

February 28, 2027

Study Completion Date

February 28, 2028

Conditions
Highly Sensitized Prospective Kidney Transplant Recipients
Interventions
BIOLOGICAL

carfilzomib

"Administered: Intravenously (IV). Carfilzomib is administered intravenously, on two consecutive days, each week for three weeks per cycle. In this study, subjects will receive 2 cycles of carfilzomib. Dosing for each cycle is based on the recommended dosing for carfilzomib monotherapy in the package insert.~Carfilzomib is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma. In this study, carfilzomib will be used in highly sensitized subjects without myeloma who are awaiting a kidney transplant."

BIOLOGICAL

belatacept

Administered: Intravenously (IV). Belatacept is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. In this study, belatacept will be used in highly sensitized subjects who are awaiting a kidney transplant.

PROCEDURE

Bone marrow aspiration

Subjects will undergo a bone marrow aspiration prior to starting the study regimen and at 16 weeks after starting the study regimen. In subjects who undergo a kidney transplant during the study, another bone marrow aspiration will be done if it has been \>4 weeks since the previous bone marrow aspiration.

Trial Locations (1)

27710

RECRUITING

Duke Transplant Center, Duke University Medical Center, Durham

All Listed Sponsors
collaborator

Immune Tolerance Network (ITN)

NETWORK

collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

PPD Development, LP

INDUSTRY

collaborator

Rho Federal Systems Division, Inc.

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH