Randomized Trial of Everolimus-Facilitated Calcineurin Inhibitor Minimization Over 24 Months in Renal Transplantation

@article{Cibrik2013RandomizedTO,
  title={Randomized Trial of Everolimus-Facilitated Calcineurin Inhibitor Minimization Over 24 Months in Renal Transplantation},
  author={Diane M. Cibrik and Helio Tedesco Silva and Anantharaman Vathsala and Eva Lackov{\'a} and Catherine Cornu-Artis and Rowan G Walker and Zailong Wang and Gazi B. Zibari and Fuad S. Shihab and Yu Seun Kim},
  journal={Transplantation Journal},
  year={2013},
  volume={95},
  pages={933–942}
}
Background Strategies allowing calcineurin inhibitor minimization while maintaining efficacy may improve renal transplant outcomes. Methods A2309 was a 24-month, phase IIIb, open-label trial of 833 de novo renal transplant recipients randomized to everolimus, targeting trough concentrations of 3–8 or 6–12 ng/mL plus reduced-exposure cyclosporine A (CsA) or to mycophenolic acid (MPA) 1.44 g per day plus standard-exposure CsA. All patients received basiliximab±corticosteroids. The incidence of… 

Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation.

In kidney transplant recipients at mild-to-moderate immunologic risk, everolimus was noninferior to MPA for a binary composite end point assessing immunosuppressive efficacy and preservation of graft function.

Everolimus-based calcineurin-inhibitor sparing regimens for kidney transplant recipients: a systematic review and meta-analysis

Everolimus-based CNI sparing regimen could optimize long-term graft function without leading to more death or graft loss, and although CNI elimination was associated with higher risk of BPAR, everolimus use with CNI minimization did not increase the risk of acute rejections.

Efficacy of everolimus with reduced-exposure cyclosporine in de novo kidney transplant patients at increased risk for efficacy events: analysis of a randomized trial

A post hoc analysis of a large, randomized trial suggests that a de novo regimen of everolimus with reduced-exposure CsA maintains immunosuppressive efficacy even in kidney transplant patients at increased risk for efficacy events despite substantial reductions in C'sA exposure.

De Novo Therapy with Everolimus and Low-Dose Calcineurin Inhibitors in Kidney Transplantation

Randomized controlled trials suggest that de novo everolimus with calcineurin inhibitor minimization provides similar efficacy, with the potential to better preserve renal function compared to standard-dose calcineURin inhibitor regimens.

Everolimus with cyclosporine withdrawal or low-exposure cyclosporine in kidney transplantation from Month 3: a multicentre, randomized trial

  • K. BuddeM. Zeier C. Sommerer
  • Medicine
    Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
  • 2017
Everolimus initiation with CNI withdrawal at Month 3 after kidney transplantation achieves a significant improvement in renal function at 12 months, with a similar rate of acute rejection.

Two‐year outcomes in de novo renal transplant recipients receiving everolimus‐facilitated calcineurin inhibitor reduction regimen from the TRANSFORM study

  • S. BergerC. Sommerer J. Pascual
  • Medicine
    American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
  • 2019
The EVR + rCNI regimen offers comparable efficacy and graft function with low tBPAR and dnDSA rates and significantly lower incidence of viral infections relative to standard‐of‐care up to 24 months.

Association of Clinical Events With Everolimus Exposure in Kidney Transplant Patients Receiving Low Doses of Tacrolimus

  • F. ShihabY. Qazi D. Shaffer
  • Medicine
    American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
  • 2017
This study supports maintaining an EVR trough concentration of 3–8 ng/mL, when combined with LTac, to achieve balanced efficacy and safety in renal transplant recipients.

Safety and Efficacy of the Early Introduction of Everolimus With Reduced-Exposure Cyclosporine A in De Novo Kidney Recipients

The results of this study provide the evidences that the calcineurin inhibitor (CNI) minimization by the introduction of everolimus after 1-month posttransplantation keeps the incidences of acute rejection and addtional risks as low as the conventional immunosuppression.

Everolimus immunosuppression in kidney transplantation: What is the optimal strategy?

Combination of calcineurin and mTOR inhibitors in kidney transplantation: a propensity score analysis based on current clinical practice

In a real-life setting, a protocol based on de-novo mTORi with tacrolimus and prednisone could be employed as a standard immunosuppressive regimen and was associated with good outcomes.
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