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J Am Soc Nephrol 15:809-817, 2004
© 2004 American Society of Nephrology

CLINICAL SCIENCE

Long-Term Benefits with Sirolimus-Based Therapy after Early Cyclosporine Withdrawal

Henri Kreis*, Rainer Oberbauer{dagger}, Josep M. Campistol{ddagger}, Timothy Mathew§, Pierre Daloze||, Francesco P. Schena, James T. Burke#, Yves Brault#, Martine Gioud-Paquet#, Joseph A. Scarola** and John F. Neylan** for the Rapamune Maintenance Regimen Trial**

*Hôpital Necker, Paris, France; {dagger}Allgemeines Krankenhaus, Vienna, Austria; {ddagger}Hospital Clinic i Provincial, Barcelona, Spain; §The Queen Elizabeth Hospital, Woodville South, Australia; ||CHUM Hôpital Notre-Dame, Montreal, Quebec, Canada; Università degli Studi di Bari, Bari, Italy; #Wyeth Research, Paris, France; and **Wyeth Research, Collegeville, Pennsylvania

Correspondence to Henri Kreis, Hôpital Necker, Service de Reanimation et de Transplantation, 149 Rue de Sevres, 75743, Paris Cedex 15, France. Phone: 33-1-44-49-54-32; Fax: 33-1-44-49-54-30; E-mail: kreis{at}necker.fr

ABSTRACT. Graft function at 6 or 12 mo is positively correlated with renal transplant survival. The 36-mo results of a study that tested whether withdrawing cyclosporine (CsA) from a sirolimus (SRL)-CsA-steroid (ST) regimen would affect renal graft survival are reported. Eligible patients (n = 430) who were receiving SRL-CsA-ST were randomly assigned at 3 mo to remain on SRL-CsA-ST or to have CsA withdrawn (SRL-ST group). At 36 mo, the calculated GFR was significantly better with SRL-ST (47.3 versus 59.4 ml/min; P < 0.001) as was the slope of the GFR (-3.6 versus 0.8 ml/min; P < 0.001). This was accompanied by growing trend for improved graft survival in the SRL-ST group (85.1% versus 91.2%, P = 0.052 at 36 mo; 81.4% versus 91.2%, P = 0.015 in a cumulative data analysis up to 54 mo), despite numerically more biopsy-proven acute rejections after randomization (5.6% versus 10.2%; P = 0.107). Lipid parameters were similar between groups, whereas both systolic and diastolic BP were significantly lower in the SRL-ST group. Investigator-reported hypertension, abnormal kidney function, edema, hyperuricemia, hyperkalemia, gingival hyperplasia, and Herpes zoster occurred significantly more often in SRL-CsA-ST patients. Abnormal liver function test results, hypokalemia, thrombocytopenia, and abnormal healing were reported significantly more often with SRL-ST. The discontinuation rate was significantly higher for SRL-CsA-ST (48% versus 38%; P = 0.041). In conclusion, withdrawing CsA from a SRL-CsA-ST regimen at 3 mo after transplantation resulted in long-term benefits for renal transplant recipients.


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