drugset / Trial / NCT01002339

Optimum Immunosuppression in Renal Transplant Recipients.New Onset Diabetes After Transplantation

NCT01002339

Phase 4 Terminated 134 enrolled Armando Torres Ramírez
RandomizedParallel-groupOpen-labelPrevention

Summary

New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. Cyclosporine (CsA) and Tacrolimus are the basis of modern immunosuppression. Tacrolimus is superior to CsA in terms of acute rejection and graft function. However, Tacrolimus increases 2 times the risk of NODAT as compared to CsA.

Timeline

Start
2010-02
Primary completion
2014-02
Completion
2015-06

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide 5 mg/kg
Subject Methylprednisolone Other / unclassified 60 mg Intravenous
Subject Methylprednisolone Other / unclassified 125 mg Intravenous
Subject Methylprednisolone Other / unclassified 0.5 g Intravenous
Subject Prednisone Other / unclassified 0.3 mg/kg Oral
Subject Prednisone Other / unclassified 30 mg Oral
Subject Tacrolimus Small molecule 0.15 mg/kg
Background Basiliximab Monoclonal antibody 4 mg Intravenous
Background Mycophenolate Mofetil Small molecule 0.5 g