PMID- 23227307
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20121212
LR  - 20211021
IS  - 2090-0015 (Electronic)
IS  - 2090-0007 (Print)
IS  - 2090-0007 (Linking)
VI  - 2012
DP  - 2012
TI  - Renal Function and NODM in De Novo Renal Transplant Recipients Treated with 
      Standard and Reduced Levels of Tacrolimus in Combination with EC-MPS.
PG  - 941640
LID - 10.1155/2012/941640 [doi]
LID - 941640
AB  - Information is lacking concerning concomitant administration of enteric-coated 
      mycophenolate sodium with tacrolimus (EC-MPS+Tac) in renal transplant recipients 
      (RTxR). In this 6-month, prospective, open-label, multicenter study, de novo RTxR 
      were randomized (1 : 1) to low-dose (LD) or standard-dose (SD) Tac with 
      basiliximab, EC-MPS 720 mg bid, and steroids. Primary objective was to compare 
      renal function at 6-month posttransplantation. Secondary objectives were to 
      compare the incidences of biopsy-proven acute rejection (BPAR), graft loss and 
      death, and new-onset diabetes mellitus (NODM). 292 patients (LD n = 151, SD n = 
      141) were included. Mean Tac levels were at the low end of the target range in 
      standard-exposure patients (SD, n = 141) and exceeded target range in 
      low-exposure patients (LD = 151) throughout the study. There was no significant 
      difference in mean glomerular filtration rate (GFR) between treatments 
      (ITT-population: 63.6 versus 61.0 mL/min). Incidence of BPAR was similar (10.6% 
      versus 9.9%). NODM was significantly less frequent in LD Tac (17% versus 31%; P = 
      0.02); other adverse effects (AEs) were comparable. EC-MPS+Tac (LD/SD) was 
      efficacious and well tolerated with well-preserved renal function. No renal 
      function benefits were demonstrated, possibly related to poor adherence to 
      reduced Tac exposure.
FAU - Chan, Laurence
AU  - Chan L
AD  - Transplant Center, University of Colorado Denver, Aurora, CO 80045, USA.
FAU - Andres, Amado
AU  - Andres A
FAU - Bunnapradist, Suphamai
AU  - Bunnapradist S
FAU - Gugliuzza, Kristene
AU  - Gugliuzza K
FAU - Parasuraman, Ravi
AU  - Parasuraman R
FAU - Peddi, V Ram
AU  - Peddi VR
FAU - Cassuto, Elisabeth
AU  - Cassuto E
FAU - Hart, Marquis
AU  - Hart M
LA  - eng
PT  - Journal Article
DEP - 20121125
PL  - United States
TA  - J Transplant
JT  - Journal of transplantation
JID - 101519118
PMC - PMC3512323
EDAT- 2012/12/12 06:00
MHDA- 2012/12/12 06:01
PMCR- 2012/11/25
CRDT- 2012/12/11 06:00
PHST- 2012/07/13 00:00 [received]
PHST- 2012/08/21 00:00 [accepted]
PHST- 2012/12/11 06:00 [entrez]
PHST- 2012/12/12 06:00 [pubmed]
PHST- 2012/12/12 06:01 [medline]
PHST- 2012/11/25 00:00 [pmc-release]
AID - 10.1155/2012/941640 [doi]
PST - ppublish
SO  - J Transplant. 2012;2012:941640. doi: 10.1155/2012/941640. Epub 2012 Nov 25.