PMID- 20500493
OWN - NLM
STAT- MEDLINE
DCOM- 20110218
LR  - 20151119
IS  - 1432-2277 (Electronic)
IS  - 0934-0874 (Linking)
VI  - 23
IP  - 11
DP  - 2010 Nov
TI  - Efficacy and safety of de novo or early everolimus with low cyclosporine in 
      deceased-donor kidney transplant recipients at specified risk of delayed graft 
      function: 12-month results of a randomized, multicenter trial.
PG  - 1084-93
LID - 10.1111/j.1432-2277.2010.01094.x [doi]
AB  - Immediate or early use of proliferation signal inhibitor (PSI)/mammalian target 
      of rapamycin (mTOR) inhibitor therapy can avoid high exposure to calcineurin 
      inhibitors but concerns exist relating to the risk of delayed graft function 
      (DGF) and impaired wound healing with the mTOR sirolimus. CALLISTO was a 
      12-month, prospective, multicenter, open-label study. Deceased-donor kidney 
      transplant patients at protocol-specified risk of DGF were randomized to start 
      everolimus on day 1 (immediate everolimus, IE; n = 65) or week 5 (delayed 
      everolimus, DE; n = 74). Incidence of the primary endpoint (biopsy-proven acute 
      rejection, BPAR; graft loss, death, DGF, wound healing complications related to 
      transplant surgery or loss to follow-up) was 64.6% and 66.2% in the IE and DE 
      groups, respectively, at month 12 (P = 0.860). The overall incidence of BPAR was 
      20.1%. Median estimated glomerular filtration rate was 48 ml/min/1.73 m(2) and 
      49 ml/min/1.73 m(2) in the IE and DE groups, respectively, at month 12. DGF and 
      wound healing complications were similar between groups. Adverse events led to 
      study drug discontinuation in 17 IE patients (26.2%) and 28 DE patients (37.8%) 
      (NS). In conclusion, introduction of everolimus immediately or early 
      posttransplant in DGF-risk patients is associated with good efficacy, renal 
      function and safety profile. There seems no benefit in delaying initiation of 
      everolimus.
CI  - (c) 2010 The Authors. Journal compilation (c) 2010 European Society for Organ 
      Transplantation.
FAU - Dantal, Jacques
AU  - Dantal J
AD  - Service de Nephrologie et Transplantation Renale, Hopital Hotel Dieu, Nantes, 
      France. jacques.dantal@chu-nantes.fr
FAU - Berthoux, Francois
AU  - Berthoux F
FAU - Moal, Marie-Christine
AU  - Moal MC
FAU - Rostaing, Lionel
AU  - Rostaing L
FAU - Legendre, Christophe
AU  - Legendre C
FAU - Genin, Robert
AU  - Genin R
FAU - Toupance, Olivier
AU  - Toupance O
FAU - Moulin, Bruno
AU  - Moulin B
FAU - Merville, Pierre
AU  - Merville P
FAU - Rerolle, Jean-Philippe
AU  - Rerolle JP
FAU - Bayle, Francois
AU  - Bayle F
FAU - Westeel, Pierre Francois
AU  - Westeel PF
FAU - Glotz, Denis
AU  - Glotz D
FAU - Kossari, Niloufar
AU  - Kossari N
FAU - Lefrancois, Nicole
AU  - Lefrancois N
FAU - Charpentier, Bernard
AU  - Charpentier B
FAU - Quere, Stephane
AU  - Quere S
FAU - Di Giambattista, Fabienne
AU  - Di Giambattista F
FAU - Cassuto, Elisabeth
AU  - Cassuto E
CN  - RAD A2420 Study Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100819
PL  - Switzerland
TA  - Transpl Int
JT  - Transplant international : official journal of the European Society for Organ 
      Transplantation
JID - 8908516
RN  - 0 (Immunosuppressive Agents)
RN  - 83HN0GTJ6D (Cyclosporine)
RN  - 9HW64Q8G6G (Everolimus)
RN  - W36ZG6FT64 (Sirolimus)
SB  - IM
EIN - Transpl Int. 2012 Jan;25(1):138
MH  - Adult
MH  - Aged
MH  - Cyclosporine/*therapeutic use
MH  - Everolimus
MH  - Female
MH  - Glomerular Filtration Rate
MH  - Graft Survival
MH  - Humans
MH  - Immunosuppressive Agents/therapeutic use
MH  - Kidney Transplantation/methods
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Risk
MH  - Sirolimus/*analogs & derivatives/therapeutic use
MH  - Treatment Outcome
MH  - Wound Healing
EDAT- 2010/05/27 06:00
MHDA- 2011/02/22 06:00
CRDT- 2010/05/27 06:00
PHST- 2010/05/27 06:00 [entrez]
PHST- 2010/05/27 06:00 [pubmed]
PHST- 2011/02/22 06:00 [medline]
AID - TRI1094 [pii]
AID - 10.1111/j.1432-2277.2010.01094.x [doi]
PST - ppublish
SO  - Transpl Int. 2010 Nov;23(11):1084-93. doi: 10.1111/j.1432-2277.2010.01094.x. Epub 
      2010 Aug 19.