Lessons Learned: Early Termination of a Randomized Trial of Calcineurin Inhibitor and Corticosteroid Avoidance Using Belatacept.
Lessons Learned: Early Termination of a Randomized Trial of Calcineurin Inhibitor and Corticosteroid Avoidance Using Belatacept.
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DOI：
10.1111/ajt.14377
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发表时间：
2017-10
期刊：
影响因子：
--
通讯作者：
Mannon RB
中科院分区：
文献类型：
--
作者：
Newell KA;Mehta AK;Larsen CP;Stock PG;Farris AB;Mehta SG;Ikle D;Armstrong B;Morrison Y;Bridges N;Robien M;Mannon RB
The intent of this NIH-sponsored study was to compare a belatacept-based immunosuppressive regimen with a maintenance regimen of tacrolimus and mycophenolate (MMF). Nineteen primary, EBV-immune renal transplant recipients with a negative cross-match were randomized to one of three groups. All patient groups received perioperative steroids and maintenance MMF. Patients in groups 1 and 2 were induced with alemtuzumab and maintained on tacrolimus or belatacept, respectively. Patients in group 3 were induced with basiliximab, received 3 months of tacrolimus, and maintained on belatacept. There was one death with a functioning allograft due to endocarditis (group 1). There were three graft losses due to vascular thrombosis (all group 2) and one graft loss due to glomerular disease (group 1). Biopsy-proven acute cellular rejection was more frequent in the belatacept treated groups, with 10 treated episodes in 7 subjects compared to 1 episode in group 1. However, eGFR was similar between groups at week 52. There were no episodes of PTLD or opportunistic infections in any group. Protocol enrollment was halted prematurely due to high rate of serious adverse events. Such negative outcomes pose challenges to clinical investigators who ultimately must weigh the risk and benefit in randomized trials.
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DOI：
10.1111/ajt.13613
发表时间：
2016-04
期刊：
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
影响因子：
--
作者：
Espinosa J;Herr F;Tharp G;Bosinger S;Song M;Farris AB 3rd;George R;Cheeseman J;Stempora L;Townsend R;Durrbach A;Kirk AD
通讯作者：
Kirk AD
影响因子：
8.8
作者：
Vincenti, F.;Charpentier, B.;Larsen, C. P.
通讯作者：
Larsen, C. P.
影响因子：
8.8
作者：
Ferguson, R.;Grinyo, J.;Garg, P.
通讯作者：
Garg, P.
影响因子：
158.5
作者：
Ojo, AO;Held, PJ;Merion, RM
通讯作者：
Merion, RM
影响因子：
8.8
作者：
Lamb, K. E.;Lodhi, S.;Meier-Kriesche, H. -U
通讯作者：
Meier-Kriesche, H. -U