drugset / Trial / NCT00138970

Calcineurin Inhibitor-Free Immunosuppression in Renal Transplant Recipients at Low Immunogenic Risk

NCT00138970

Phase 4 Completed 70 enrolled University of Oslo School of Pharmacy
RandomizedParallel-groupOpen-labelPrevention

Summary

To compare renal function (51Cr-EDTA clearance) 12 months posttransplant, in primary renal allograft recipients (from cadaveric donor) at low immunogenic risk, 0 DR mis-match, receiving immunosuppressive therapy with A) Zenapax® (5 doses), CellCept® (1.5 g bid., aiming for TDM for total trough concentrations of 2-6 mg/L) and prednisolone or B) Sandimmun Neoral® (full dose), CellCept® (1.0 g bid.) and prednisolone.

Timeline

Start
2002-01
Primary completion
Completion
2005-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide
Subject Daclizumab Monoclonal antibody
Subject Mycophenolate Mofetil Small molecule 1 g
Subject Mycophenolate Mofetil Small molecule 1.5 g
Background Prednisolone Other / unclassified