期刊
AMERICAN JOURNAL OF TRANSPLANTATION
卷 20, 期 12, 页码 3609-3619出版社
WILEY
DOI: 10.1111/ajt.16121
关键词
clinical research; practice; clinical trial; costimulation; graft survival; immunosuppression; immune modulation; kidney transplantation; nephrology
资金
- US Food and Drug Administration Office of Orphan Products Development [1R01FD003539]
Kidney transplant outcomes are limited by toxicities associated with calcineurin inhibitors and steroids. This trial was conducted to determine whether a costimulation blockade (CoB)-based regimen could achieve acceptable long-term outcomes and graft survival could be maintained solely with CoB. Forty patients underwent alemtuzumab induction followed by belatacept and sirolimus maintenance therapy. Patients were offered weaning to belatacept monotherapy after 1 year and followed for 5 years. Five-year patient and graft survival rates were 100% and 95%, respectively. Graft function remained stable with a mean estimated glomerular filtration rates of 67 +/- 21 and 71 +/- 19 at 36 and 60 months, respectively. There was no clinical rejection in the first year; subclinical rejection was detected by protocol biopsy in 4 patients. Twelve patients were successfully weaned to belatacept monotherapy. Cytomegalovirus and Epstein-Barr virus reactivations were well controlled, but 9 patients experienced transient BK viremia during the first year. Alemtuzumab produced profound lymphopenia followed by gradual T cell and more rapid B cell reconstitution to a repertoire deviated toward naive cells with increased regulatory T cells. This regimen effectively prevents allograft rejection without using steroids or calcineurin inhibitors, enriches for naive cells susceptible to control with CoB, and permits control of rejection with belatacept monotherapy in selected patients.
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