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Randomized Controlled Trial
. 2009 Jan-Feb;23(1):9-15.
doi: 10.1111/j.1399-0012.2008.00880.x. Epub 2008 Aug 18.

Immunosuppression without calcineurin inhibition: optimization of renal function in expanded criteria donor renal transplantation

Affiliations
Randomized Controlled Trial

Immunosuppression without calcineurin inhibition: optimization of renal function in expanded criteria donor renal transplantation

Patrick P W Luke et al. Clin Transplant. 2009 Jan-Feb.

Abstract

Introduction: To assess the efficacy of calcineurin inhibitor (CNI)-free immunosuppression vs. calcineurin-based immunosuppression in patients receiving expanded criteria donor (ECD) kidneys.

Patient and methods: Thirteen recipients of ECD kidneys were enrolled in this pilot study and treated with induction therapy and maintained on sirolimus, mycophenolate mofetil (MMF) and prednisone. A contemporaneous control group was randomly selected comprised of 13 recipients of ECD kidneys who had been maintained on CNI plus MMF and prednisone.

Results: For the study group vs. the control group, two-yr graft survival was 92.3% vs. 84.6% (p = NS), two-yr patient survival was 100% vs. 92.3% (p = NS) and the acute rejection rates were 23% vs. 31% (p = NS), respectively. Renal function was significantly better in the study group compared with control up to the six-month mark, after which, it remained numerically but not statistically significant. Complications were more common in the study group, but serious adverse events requiring discontinuation were rare.

Conclusion: This pilot study demonstrates that CNI-free regimens can be safely implemented in patients receiving ECD kidneys with excellent two-yr patient and graft survival and good renal allograft function. Longer follow-up in larger randomized controlled trials are necessary to establish these findings.

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