Impact of early or delayed cyclosporine on delayed graft function in renal transplant recipients: a randomized, multicenter study.
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 C2 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 51.1 mL/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.
Kamar
N
N
Department of Nephrology-Transplantation, Hôpital Rangueil, Toulouse, France. kamar.n@chu-toulouse.fr
Garrigue
V
V
Karras
A
A
Mourad
G
G
Lefrançois
N
N
Charpentier
B
B
Legendre
C
C
Rostaing
L
L
D000328:Adult; D016572:Cyclosporine / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007518:Isoantibodies / Q000097:blood; D016030:Kidney Transplantation / Q000276:immunology / Q000473:pathology / Q000502:physiology*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011183:Postoperative Complications / Q000139:chemically induced / Q000453:epidemiology; D011446:Prospective Studies; D013608:Tablets, Enteric-Coated; D017211:Treatment Failure; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D007518:Isoantibodies; D013608:Tablets, Enteric-Coated; D016572:Cyclosporine