drugset / Trial / NCT01802268

Planned Conversion From TAC to SRL-based Regimen in de Novo Kidney Transplant Recipients

NCT01802268

Phase 4 Completed 320 enrolled Helio Tedesco Silva Junior Pfizer · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate long-term CNi associated adverse events. This study aims to evaluate the conversion from tacrolimus to sirolimus in de novo kidney transplant recipients. This multicenter, open-label study, planned to enroll 297 patients initially treated with tacrolimus, enteric-coated mycophenolate sodium (1440 mg/day, orally) and prednisone. The primary objective is to show superior glomerular filtration rate in the SRL group at 24 months after transplantation.

Timeline

Start
2008-02
Primary completion
2012-04
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sirolimus Small molecule
Comparator Tacrolimus Small molecule

Indications

No indication recorded.