drugset
drugset / Trial / NCT01817322

Kidney Graft Function Under the Immunosuppression Strategies

NCT01817322 ↗

Phase 4 Completed 140 enrolled Samsung Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

To demonstrate that cyclosporine-sparing immunosuppressions with the standard dose of Enteric-Coated Mycophenolate Sodium would preserve renal graft function after transplantation without an increase of incidences of adverse events, such as biopsy confirmed acute rejection, local or systemic infections, and bone marrow suppression.

Timeline

Start
2011-06
Primary completion
2013-08
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide 10 mg/kg Oral
Subject Mycophenolate Sodium Unknown 360 mg Oral
Subject Mycophenolate Sodium Unknown 720 mg Oral
Background Basiliximab Monoclonal antibody 20 mg Intravenous
Background Deflazacort Other / unclassified 6 mg Intravenous
Background Methylprednisolone Other / unclassified 4 mg Intravenous
Background Prednisolone Other / unclassified 5 mg Intravenous

Indications

chronic kidney disease