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Renal transplantation using belatacept without maintenance steroids or calcineurin inhibitors.
Am J Transplant. 2014 May; 14(5):1142-51.AJ

Abstract

Kidney transplantation remains limited by toxicities of calcineurin inhibitors (CNIs) and steroids. Belatacept is a less toxic CNI alternative, but existing regimens rely on steroids and have higher rejection rates. Experimentally, donor bone marrow and sirolimus promote belatacept's efficacy. To investigate a belatacept-based regimen without CNIs or steroids, we transplanted recipients of live donor kidneys using alemtuzumab induction, monthly belatacept and daily sirolimus. Patients were randomized 1:1 to receive unfractionated donor bone marrow. After 1 year, patients were allowed to wean from sirolimus. Patients were followed clinically and with surveillance biopsies. Twenty patients were transplanted, all successfully. Mean creatinine (estimated GFR) was 1.10 ± 0.07 mg/dL (89 ± 3.56 mL/min) and 1.13 ± 0.07 mg/dL (and 88 ± 3.48 mL/min) at 12 and 36 months, respectively. Excellent results were achieved irrespective of bone marrow infusion. Ten patients elected oral immunosuppressant weaning, seven of whom were maintained rejection-free on monotherapy belatacept. Those failing to wean were successfully maintained on belatacept-based regimens supplemented by oral immunosuppression. Seven patients declined immunosuppressant weaning and three patients were denied weaning for associated medical conditions; all remained rejection-free. Belatacept and sirolimus effectively prevent kidney allograft rejection without CNIs or steroids when used following alemtuzumab induction. Selected, immunologically low-risk patients can be maintained solely on once monthly intravenous belatacept.

Authors+Show Affiliations

Emory Transplant Center, Emory University, Atlanta, GA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

24684552

Citation

Kirk, A D., et al. "Renal Transplantation Using Belatacept Without Maintenance Steroids or Calcineurin Inhibitors." American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons, vol. 14, no. 5, 2014, pp. 1142-51.
Kirk AD, Guasch A, Xu H, et al. Renal transplantation using belatacept without maintenance steroids or calcineurin inhibitors. Am J Transplant. 2014;14(5):1142-51.
Kirk, A. D., Guasch, A., Xu, H., Cheeseman, J., Mead, S. I., Ghali, A., Mehta, A. K., Wu, D., Gebel, H., Bray, R., Horan, J., Kean, L. S., Larsen, C. P., & Pearson, T. C. (2014). Renal transplantation using belatacept without maintenance steroids or calcineurin inhibitors. American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 14(5), 1142-51. https://doi.org/10.1111/ajt.12712
Kirk AD, et al. Renal Transplantation Using Belatacept Without Maintenance Steroids or Calcineurin Inhibitors. Am J Transplant. 2014;14(5):1142-51. PubMed PMID: 24684552.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Renal transplantation using belatacept without maintenance steroids or calcineurin inhibitors. AU - Kirk,A D, AU - Guasch,A, AU - Xu,H, AU - Cheeseman,J, AU - Mead,S I, AU - Ghali,A, AU - Mehta,A K, AU - Wu,D, AU - Gebel,H, AU - Bray,R, AU - Horan,J, AU - Kean,L S, AU - Larsen,C P, AU - Pearson,T C, Y1 - 2014/03/31/ PY - 2013/12/09/received PY - 2014/01/27/revised PY - 2014/02/12/accepted PY - 2014/4/2/entrez PY - 2014/4/2/pubmed PY - 2015/1/21/medline KW - Alemtuzumab KW - belatacept KW - costimulation KW - immunosuppressive regimens KW - minimization/withdrawal KW - sirolimus SP - 1142 EP - 51 JF - American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons JO - Am. J. Transplant. VL - 14 IS - 5 N2 - Kidney transplantation remains limited by toxicities of calcineurin inhibitors (CNIs) and steroids. Belatacept is a less toxic CNI alternative, but existing regimens rely on steroids and have higher rejection rates. Experimentally, donor bone marrow and sirolimus promote belatacept's efficacy. To investigate a belatacept-based regimen without CNIs or steroids, we transplanted recipients of live donor kidneys using alemtuzumab induction, monthly belatacept and daily sirolimus. Patients were randomized 1:1 to receive unfractionated donor bone marrow. After 1 year, patients were allowed to wean from sirolimus. Patients were followed clinically and with surveillance biopsies. Twenty patients were transplanted, all successfully. Mean creatinine (estimated GFR) was 1.10 ± 0.07 mg/dL (89 ± 3.56 mL/min) and 1.13 ± 0.07 mg/dL (and 88 ± 3.48 mL/min) at 12 and 36 months, respectively. Excellent results were achieved irrespective of bone marrow infusion. Ten patients elected oral immunosuppressant weaning, seven of whom were maintained rejection-free on monotherapy belatacept. Those failing to wean were successfully maintained on belatacept-based regimens supplemented by oral immunosuppression. Seven patients declined immunosuppressant weaning and three patients were denied weaning for associated medical conditions; all remained rejection-free. Belatacept and sirolimus effectively prevent kidney allograft rejection without CNIs or steroids when used following alemtuzumab induction. Selected, immunologically low-risk patients can be maintained solely on once monthly intravenous belatacept. SN - 1600-6143 UR - https://www.unboundmedicine.com/medline/citation/24684552/Renal_transplantation_using_belatacept_without_maintenance_steroids_or_calcineurin_inhibitors_ L2 - https://doi.org/10.1111/ajt.12712 DB - PRIME DP - Unbound Medicine ER -