Renal function to 5 years after late conversion of kidney transplant patients to everolimus: a randomized trial

Springer Science and Business Media LLC - Tập 28 - Trang 115-123 - 2014
Klemens Budde1, Claudia Sommerer2, Thomas Rath3, Petra Reinke4, Hermann Haller5, Oliver Witzke6, Barbara Suwelack7, Daniel Baeumer8, Christian Sieder8, Martina Porstner8, Wolfgang Arns9
1Department of Nephrology, Charité Universitätsmedizin Berlin, Berlin, Germany
2Department of Nephrology, Heidelberg University Hospital, Heidelberg, Germany
3Department of Nephrology and Transplantation Medicine, Westpfalz-Klinikum, Kaiserslautern, Germany
4Division of Internal Medicine and Nephrology, Department of Transplantation, Charité Universitätsmedizin Berlin, Berlin, Germany
5Department of Nephrology and Hypertensiology, Hannover Medical School, Hannover, Germany
6Department of Nephrology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany
7Department of Internal Medicine D, Transplant Nephrology, University of Münster, Münster, Germany
8Novartis Pharma GmbH, Nuernberg, Germany
9Department of Nephrology and Transplantation, Cologne Merheim Medical Center, University of Witten/Herdecke, Cologne, Germany

Tóm tắt

Few trials have investigated late preemptive conversion of kidney transplant patients from a calcineurin inhibitor (CNI) to an mTOR inhibitor. In an open-label, 12-month, prospective, randomized, parallel-group study, maintenance kidney transplant patients (>6 months post-transplant) either switched from CNI to everolimus or continued their current CNI regimen. Patients who completed the core study were followed to 5 years post-randomization. Of 93 randomized patients, 78 completed the core study and 67 attended the final 60-month study visit. Mean time post-transplant at baseline was 82.6 months and 70.5 months in the everolimus and CNI groups, respectively. At month 60, adjusted mean eGFR (Nankivell) was 63.0 (95 % CI 57.8, 68.2) mL/min/1.73 m2 in the everolimus group versus 57.9 (95 % CI 52.6, 63.1) mL/min/1.73 m2 in the CNI group, a difference of 5.1 (95 % CI −0.6, 10.8) mL/min/1.73 m2 (p = 0.076). Among patients who remained on randomized study drug at month 60, mean eGFR (Nankivell) was 71.6 (95 % CI 64.2, 79.0) mL/min/1.73 m2 in everolimus-treated patients (n = 21) versus 60.6 (95 % CI 55.1, 66.1) mL/min/1.73 m2 in CNI-treated patients (n = 29) (mean difference 11.0; 95 % CI 3.6, 18.5 mL/min/1.73 m2; p = 0.005). No cases of BPAR occurred from randomization to month 60 in either group. Graft loss occurred in three everolimus-treated patients and one CNI-treated patient. No unexpected safety concerns were observed in either group. Late preemptive conversion of maintenance kidney transplant patients from CNI to everolimus may be associated with improved long-term renal function and preserves immunosuppressive efficacy. Patient numbers were low, but these findings merit further investigation.

Tài liệu tham khảo

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