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Impact of Early or Delayed Cyclosporine on Delayed Graft Function in Renal Transplant Recipients: A Randomized, Multicenter Study
Author(s) -
Kamar N.,
Garrigue V.,
Karras A.,
Mourad G.,
Lefrançois N.,
Charpentier B.,
Legendre C.,
Rostaing L.
Publication year - 2006
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/j.1600-6143.2006.01291.x
Subject(s) - medicine , renal transplant , renal function , multicenter study , randomized controlled trial , urology , transplantation
The benefit of delayed cyclosporine in reducing risk of delayed graft function (DGF) is not clearly established. This study compared early vs. delayed cyclosporine microemulsion (CsA‐ME) inde novorenal transplant patients. Patients were randomized to early (day 0, n = 97) or delayed (day 6, n = 100) CsA‐ME at an initial dose of 8 mg/kg/day with dose adjusted according to C 2 level. All patients received enteric‐coated mycophenolate sodium (EC‐MPS), steroids and an anti‐interleukin‐2 receptor antibody. In both groups, 33% of patients were at high risk of DGF; 26 patients (26.8%) in the early CsA‐ME group and 23 patients (23.0%) in the delayed CsA‐ME group experienced DGF (n.s.). Renal function at 3 months was comparable (creatinine clearance 51.1mL/min with early CsA‐ME and 53.8 mL/min with delayed CsA‐ME), and remained similar to 12 months. Treatment failure, defined as biopsy‐proven acute rejection, graft loss or death, did not differ significantly at 12 months (23.7% with early CsA‐ME vs. 29.0% with delayed CsA‐ME). Biopsy‐proven acute rejection occurred in 15.5% of early CsA‐ME and 26.5% of delayed CsA‐ME patients (n.s.). Both regimens were well tolerated. These data suggest that early or delayed introduction of CsA‐ME results in similar renal function in renal transplant patients regardless of DGF risk level.