Measuring Allospecific Impact of Belatacept/Carfilzomib Desensitization (ADAPT)

Principal Investigator

Stuart Knechtle, MD | Duke University Hospital

Locations

Duke University Hospital | Durham, NC

Study Code

ITN089ST

Study Status

Active

Abstract

ADAPT is a clinical study to learn whether a new treatment plan can increase the chances for highly sensitized kidney transplant candidates to find a kidney donor match.

Highly sensitized patients whose immune systems are much more likely to react against donated organs could have to wait a very long time to find a donor kidney that their immune system will accept.

Since plasma cells make antibodies, ADAPT will investigate whether using carfilzomib (Kyprolis®) and belatacept (Nulojix®) together can reduce the number of plasma cells in "highly sensitized" people while they are on the kidney transplant waiting list. This process is called desensitization and would improve the chances of finding a "matching" donor and reduce the risk of rejection after transplant.

Participants will have a total of 12 infusions of carfilzomib and 16 doses of belatacept. Research samples (blood, tissue, and bone marrow cells) will be collected during this study.

Study participation will last 76 weeks (18 months). If the participant receives a transplant during their time in the study, there will be extra follow up for 1 year.

Phase	# of Visits	How Long Phase Lasts
Screening and Enrollment	2 - 4	Up to 12 weeks
Study Treatment	26	52 weeks
Follow-up	1 - 9	12-51 weeks
Extra follow up if you get a transplant while in the study	15	52 weeks after transplant