Daratumumab plus belatacept desensitization trial (ATTAIN)

Principal Investigator

Flavio G. Vincenti, MD | University of California, San Francisco Medical Center

Locations

University of California, San Francisco Medical Center | San Francisco, CA

Study Code

ITN090ST

Study Status

Active

Abstract

ATTAIN is a clinical trial to learn whether a new drug treatment plan can increase the chances for a highly sensitized kidney transplant candidate to find a well-matched kidney donor.

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, ATTAIN will investigate whether using daratumumab (Darzalex®) and belatacept (Nulojix®) together can lower the number of plasma cells in “highly sensitized” people on the kidney transplant waiting list. With fewer plasma cells, fewer antibodies to kidney donor cells might be made. This would improve the chances of finding a "matching" donor and reduce the risk of rejection after transplant.

Participants will have a total of 10 infusions of the study drugs: 6 infusions of daratumumab, and 4 infusions of belatacept. Research samples (blood, tissue, and bone marrow cells) will be collected during this study.

Study participation will last 60 weeks (14 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

2

4 weeks

Study Treatment

10

14 weeks

Follow-up

5-7

42-52 weeks

Extended follow-up if transplant is received during the study

6

52 weeks after transplant

Articles

DOI: 

http://dx.doi.org/10.1016/j.celrep.2023.112682

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PMID: 

37355988

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PMCID: 

PMC10391632

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PubMed

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