drugset / Trial / NCT00138970
Calcineurin Inhibitor-Free Immunosuppression in Renal Transplant Recipients at Low Immunogenic Risk
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |