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A Controlled Trial Comparing Two Doses of Cyclosporine in Conjunction with Mycophenolate Mofetil and Corticosteroids

RUUD G. L. DE SÉVAUX^*, PETER J. H. SMAK GREGOOR, RONALD J. HENÉ, ANDRIES J. HOITSMA^*, PIETER VOS, WILLEM WEIMAR, TEUN VAN GELDER and LUKAS B. HILBRANDS^*

^* Department of Nephrology, University Hospital of Nijmegen, The Netherlands.
Department of Nephrology, University Hospital of Rotterdam, The Netherlands.
Department of Nephrology, University Hospital of Utrecht, The Netherlands.

Correspondence to Dr. Ruud de Sévaux, Department of Nephrology, University Hospital Nijmegen, P.O. Box 9101; 6500 HB Nijmegen, The Netherlands. Phone: +31-24-3614761; Fax: +31-24-3540022; E-mail: R.deSevaux{at}nefro.azn.nl

Abstract. It is unknown whether the addition of mycophenolate mofetil (MMF) to cyclosporine (CsA) and prednisone after renal transplantation (RTx) allows for a reduced dose of CsA, to minimize the incidence of CsA-related side effects and to reduce costs. Therefore, 313 renal allograft recipients were randomized for treatment with MMF (1000 mg twice a day), prednisone, and either conventional- or low-dose CsA during the first 3 mo after RTx. The target trough levels were 300 and 150 ng/ml, respectively, during the first 3 mo and 150 ng/ml in both groups thereafter. A total of 313 patients were included: 161 patients received a conventional dose and 152 received a low dose of CsA. During the first 6 mo after RTx, graft failure or patient death occurred in 19 of 161 patients (12%) in the conventional-dose group and in 11 of 152 patients (7%) in the low-dose group (not significant). Biopsy-proven acute rejection occurred in 36 of 161 patients (22%) in the conventional-dose group and in 29 of 152 patients (19%) in the low-dose group (not significant). The incidence of delayed graft function was similar in both groups (31 of 161 [19%] versus 28 of 152 [18%]; not significant). Serum creatinine did not differ between the conventional- and the low-dose groups: 151 ± 56 µmol/L versus 142 ± 49 µmol/L at 3 mo and 141 ± 60 µmol/L versus 136 ± 49 µmol/L at 6 mo. There were no differences between the groups regarding BP, lipid metabolism, and infectious complications. In the low-dose group, an estimated $500 per patient was saved on the costs of CsA. In conclusion, the addition of MMF to CsA and prednisone after RTx allows the use of a lower-than-conventional dose of CsA, without increasing the risk of rejection.

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