Renal Function and NODM in De Novo Renal Transplant Recipients Treated with Standard and Reduced Levels of Tacrolimus in Combination with EC-MPS
Joint Authors
Cassuto-Viguier, E.
Parasuraman, Ravi
Peddi, V. Ram
Chan, Laurence
Hart, Marquis
Bunnapradist, Suphamai
Gugliuzza, Kristene
Andres, Amado
Source
Issue
Vol. 2012, Issue 2012 (31 Dec. 2012), pp.1-9, 9 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2012-11-25
Country of Publication
Egypt
No. of Pages
9
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Chan, Laurence& Andres, Amado& Bunnapradist, Suphamai& Gugliuzza, Kristene& Parasuraman, Ravi& Peddi, V. Ram…[et al.]. 2012. Renal Function and NODM in De Novo Renal Transplant Recipients Treated with Standard and Reduced Levels of Tacrolimus in Combination with EC-MPS. Journal of Transplantation،Vol. 2012, no. 2012, pp.1-9.
https://search.emarefa.net/detail/BIM-510031
Modern Language Association (MLA)
Chan, Laurence…[et al.]. Renal Function and NODM in De Novo Renal Transplant Recipients Treated with Standard and Reduced Levels of Tacrolimus in Combination with EC-MPS. Journal of Transplantation No. 2012 (2012), pp.1-9.
https://search.emarefa.net/detail/BIM-510031
American Medical Association (AMA)
Chan, Laurence& Andres, Amado& Bunnapradist, Suphamai& Gugliuzza, Kristene& Parasuraman, Ravi& Peddi, V. Ram…[et al.]. Renal Function and NODM in De Novo Renal Transplant Recipients Treated with Standard and Reduced Levels of Tacrolimus in Combination with EC-MPS. Journal of Transplantation. 2012. Vol. 2012, no. 2012, pp.1-9.
https://search.emarefa.net/detail/BIM-510031
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-510031