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

• Published in: Journal of the American Society of Nephrology Vol. 19; no. 6; pp. 1225 - 1232
• Main Authors: HAMDY, Ahmed F, BAKR, Mohamed A, GHONEIM, Mohamed A
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 01-06-2008; American Society of Nephrology
• Subjects: Adaptor Proteins, Signal Transducing; Biological and medical sciences; Calcineurin; Clinical Research; Follow-Up Studies; Humans; Immunosuppression Therapy - methods; Immunosuppressive Agents - therapeutic use; Kidney Transplantation; Living Donors; Medical sciences; Mycophenolic Acid - analogs & derivatives; Mycophenolic Acid - therapeutic use; Nephrology. Urinary tract diseases; Prospective Studies; Sirolimus - therapeutic use; Tacrolimus - therapeutic use; Time Factors; Nephrology; Toxicity; Calcineurin; Living donor; Treatment efficiency; Free form; Transplantation; Homotransplantation; Long term; Kidney; Urology; Treatment; Urinary system; Surgery; Graft; Inhibitor; Therapeutic protocol
• DOI: 10.1681/ASN.2007091001
• EISSN: 1533-3450
• ISSN: 1046-6673

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.