Assessment of two strategies of neoral administration, early versus delayed, on renal function and efficacy in de novo renal transplant patients receiving myfortic, steroids, and anti-IL2R antibodies: 12-month results of a randomized, multicentre, open, prospective controlled study.
The optimal immunosuppressive strategy and benefit of delaying Neoral to prevent delayed graft function (DGF) have not been clearly established. Renal function was assessed by estimated creatinine clearance (Cockcroft-Gault) at 3 months, and efficacy by treatment failure and BPAR at 6 and 12 months after renal transplantation. Two hundred three patients were enrolled after stratification according to DGF risk (USRDS criteria). One hundred ninety-seven were randomized to receive either early (E; day 0; n = 97) or delayed (D; day 6; n = 100) Neoral in combination with myfortic, steroids, and anti-IL2R antibodies. Neoral was adjusted using C2. Six patients who were not randomized have been excluded from the intention-to-treat (ITT) analysis.


RESULTS
There was no significant difference in the demographic or baseline parameters between the two groups. The risk of DGF(score > or = 5) was similar in both groups: 32 of 97 in E-Neoral versus 33 of 100 in D-Neoral. In the group at high risk for DGF, the incidence of DGF was 13 of 32 pts in E-Neoral versus 14 of 33 in D-Neoral. Renal function was not statistically different between the two groups in both the ITT and per-protocol (PP) populations at 3, 6, or 12 months. Over 12 months, the evidence of treatment failure and BPAR were not statistically different: 24 of 97 (24.7%) versus 27 of 100 (27%) and 18 of 97 (18.6%) versus 24 of 100 (24%) for E-Neoral and D-Neoral, respectively. The severity of acute rejection was mild in 83% patients.


CONCLUSIONS
These data suggest that there is no significant impact on renal function and immunosuppressing efficacy of early versus delayed introduction of Neoral, in combination with myfortic and steroids among renal transplant patients with or without a risk of DGF.
Mourad
G
G
Department of Nephrology-Transplantation University Hospital of Lapeyronie, Montpellier, France.
Rostaing
L
L
Legendre
Ch
Ch
D000208:Acute Disease; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D002102:Cadaver; D002908:Chronic Disease; D016572:Cyclosporine / Q000008:administration & dosage* / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D006084:Graft Rejection / Q000453:epidemiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000276:immunology / Q000401:mortality / Q000502:physiology*; D019520:Living Donors; D011183:Postoperative Complications / Q000145:classification / Q000453:epidemiology; D016019:Survival Analysis; D014019:Tissue Donors; D017211:Treatment Failure
D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D016572:Cyclosporine