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Pediatric patients that received a transplanted kidney will receive immunosuppressive medication-the calcineurin inhibitor (tacrolimus) and antiproliferative agent (MMF)-until they will be randomized ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2010-024381-21

Pediatric patients that received a transplanted kidney will receive immunosuppressive medication-the calcineurin inhibitor (tacrolimus) and antiproliferative agent (MMF)-until they will be randomized between week 4 and 6 to receive either the same treatment or to switch to the investigational drug everolimus. The patients will be followed up until 3 years after transplantation to evaluate the efficacy, tolerability and safety of the treatments and to assess their impact on renal function

Femme et Homme

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Extrait

- To estimate the rate of the composite efficacy endpoint of BPAR, graft loss or death at 12 months post transplantation in primary paediatric kidney transplant recipients converted at 4-6 weeks post-transplantation from MMF + standard TAC regimen and steroids, to everolimus + reduced dose TAC regimen and steroid withdrawal at 6 months, versus continuation of MMF + standard TAC regimen and steroids. - To evaluate renal function assessed by Glomerular Filtration Rate (eGFR) estimated by the Schwartz formula (abbreviated) at month 12.

Critère d'inclusion

  • Prevention of acute rejection in paediatric recipients of a renal transplant

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