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January 20, 2009Transplantation

Conversion From Calcineurin Inhibitors to Sirolimus Maintenance Therapy in Renal Allograft Recipients: 24-Month Efficacy and Safety Results From the CONVERT Trial

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Authors

FSFrancesco Paolo SchenaUniversity of Bari Aldo MoroMPM.D. PascoeUniversity of Cape TownJAJosefina AlberúInstituto Tecnológico Autónomo de México

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Implication

Randomized trial demonstrates improved kidney function and reduced malignancy after sirolimus conversion in kidney transplant recipients, indicating benefit in patients with preserved baseline GFR.

Key Points

  • To evaluate the 24-month efficacy and safety of converting maintenance kidney transplant recipients from calcineurin inhibitors (cyclosporine or tacrolimus) to sirolimus.
  • Randomized trial of 830 renal allograft recipients (6 to 120 months posttransplant) assigned to continue calcineurin inhibitor therapy (n=275) or convert to sirolimus (n=555).
  • Primary endpoints were calculated Nankivell glomerular filtration rate (GFR; stratified at baseline: 20-40 vs. >40 mL/min) and cumulative rates of biopsy-confirmed acute rejection, graft loss, or death at 12 months, with follow-up through 24 months.
  • Enrollment in the baseline GFR 20 to 40 mL/min stratum was stopped prematurely due to an increased rate of safety endpoints in the sirolimus conversion arm.
  • In the baseline GFR >40 mL/min stratum, intent-to-treat analyses showed no statistically significant difference in GFR at 12 or 24 months, but on-therapy analysis demonstrated significantly higher GFR following sirolimus conversion.
  • Sirolimus conversion led to significantly lower malignancy rates at 12 and 24 months alongside significantly increased median urinary protein-to-creatinine ratios compared with calcineurin inhibitor continuation.
  • Post hoc analysis identified that patients with baseline GFR >40 mL/min and urinary protein-to-creatinine ratio ≤0.11 experienced the most favorable risk-benefit profile after conversion.

Cite This Study

Schena et al. (2009) studied this question.

synapsesocial.com/papers/6a033c8759ea043e4c9e482dhttps://doi.org/10.1097/tp.0b013e3181927a41
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