A comparative, Randomized trial of Concentration-Controlled Sirolimus Combined With Reduced-Dose Tacrolimus or Standard-Dose Tacrolimus in Renal Allograft Recipients
Bechstein, W.O; Paczeck, L; Wramner, Let al.
2013 • In Transplantation Proceedings, 45, p. 2133-2140
[en] The clinical safety and efficacy of sirolimus plus reduced-dose tacrolimus
was evaluated in de novo renal allograft recipients enrolled in a comparative, open-label
study.
Methods. One hundred twenty-eight renal allograft recipients were randomly assigned
(1:1) to receive reduced-dose tacrolimus plus sirolimus (rTAC) or standard-dose
tacrolimus and sirolimus (sTAC) for 6 months. The primary efficacy endpoint was
calculated creatinine clearance values at 6 months.
Results. Demographic variables were similar between groups. At 6 months, mean
( standard deviation) calculated creatinine clearance was significantly improved in the
rTAC group (63.8 vs 52.7 mL/min, P ¼ .005), although mean serum creatinine values were
not significantly different. Patient survival (95.2% and 96.9%) and graft survival (93.7%
and 98.5%) were similar between the rTAC and sTAC groups, respectively. Acute rejection
rates were 17.5% with rTAC and 7.7% with sTAC (P ¼ .095).
Conclusions. The rTAC regimen provided effective immunosuppression and was associated
with improved creatinine clearance. Adequate immunosuppressant exposure must
be achieved in the early postoperative period to minimize the risk of acute rejection.
Disciplines :
Surgery
Author, co-author :
Bechstein, W.O
Paczeck, L
Wramner, L
SQUIFFLET, Jean-Paul ; Centre Hospitalier Universitaire de Liège - CHU > Chirurgie abdominale- endocrinienne et de transplantation
Zygmunt, A.J
Language :
English
Title :
A comparative, Randomized trial of Concentration-Controlled Sirolimus Combined With Reduced-Dose Tacrolimus or Standard-Dose Tacrolimus in Renal Allograft Recipients
Publication date :
2013
Journal title :
Transplantation Proceedings
ISSN :
0041-1345
eISSN :
1873-2623
Publisher :
Elsevier Science, New York, United States - New York
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