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Published ahead of print on March 12, 2008
J Am Soc Nephrol 19: 1225-1232, 2008
© 2008 American Society of Nephrology
doi: 10.1681/ASN.2007091001
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CLINICAL RESEARCH

Long-term Efficacy and Safety of a Calcineurin Inhibitor-free Regimen in Live-Donor Renal Transplant Recipients

Ahmed F. Hamdy, Mohamed A. Bakr and Mohamed A. Ghoneim

Urology and Nephrology Center, Mansoura University, Mansoura, Egypt

Correspondence: Ahmed Farouk Hamdy, Urology and Nephrology Center, Mansoura University, Al-gomhoria Street, Mansoura, Egypt 35516. Phone: 002050-226-2222; Fax: 002050-226-3717; E-mail: afhamdy{at}yahoo.com

Received for publication September 12, 2007. Accepted for publication December 9, 2007.

Calcineurin inhibitor (CNI) nephrotoxicity is a major concern after renal transplantation. To investigate the safety and efficacy of a CNI-free immunosuppressive regimen, 132 live-donor renal transplant recipients were included in a prospective, randomized controlled trial. All patients received induction therapy with basiliximab and steroids. The patients were randomized to a maintenance immunosuppression regimen that included steroids, sirolimus, and either low-dose tacrolimus or mycophenolate mofetil (MMF). Over a mean follow-up period of approximately 5 yr, patient and graft survival did not significantly differ between the two maintenance regimens. Patient survival was 93.8% and 98.5% in the tacrolimus/sirolimus and MMF/sirolimus groups, respectively, and graft survival was 83% and 88%, respectively. However, the MMF/sirolimus group had significantly better renal function, calculated by Cockcroft-Gault, from the second year post-transplant until the last follow-up. In addition, this group was less likely to require a change in their primary immunosuppression regimen than the tacrolimus/sirolimus group (20.8% versus 53.8%, P = 0.001). The safety profile was similar between groups. In summary, after long-term follow-up, a CNI-free maintenance regimen consisting of sirolimus, MMF, and steroids was both safe and efficacious among low to moderate immunologic risk renal transplant recipients.


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