Calcineurin Inhibitor-Free Immunosuppression in Renal Transplant Recipients at Low Immunogenic Risk
|Renal Transplant Recipients||Drug: Zenapax®, CellCept® and prednisolone Drug: Sandimmun Neoral®, CellCept® and prednisolone||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Randomised, Double-Arm, Controlled, Open-Label Study Comparing Calcineurin Inhibitor-Free Immunosuppression (Zenapax®, CellCept® and Prednisolone) and Cyclosporine A Based Immunosuppression (Sandimmun Neoral®, CellCept® and Prednisolone) on the Outcome of Renal Function and Acute Rejection in 0 DR Mis-Matched Renal Allograft Recipients|
- The primary efficacy endpoint is the renal function, evaluated by 51Cr-EDTA clearance and normalized for 1.73 m2 body-surface, at 12 months posttransplant.
- • Combined patient and graft survival at 12 months posttransplant.
- • Proportion of patients with biopsy-proven acute rejection or acute rejection (biopsy proven + presumptive) episode at 3 and 12 month posttransplant.
- • Incidence and severity of hypertension at 10 weeks and 12 months posttransplant.
- • Incidence and severity of dyslipidemia at 10 weeks and 12 months posttransplant.
- • Incidence of glucose intolerance at 10 weeks and 12 months posttransplant.
- • Incidence of treatment failure at 12 months posttransplant.
- • Success rate of TDM guided CellCept® dosing at 3 months posttransplant.
- • Infection rate.
|Study Start Date:||January 2002|
|Estimated Study Completion Date:||February 2005|
Primary Objective 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.
Secondary Objectives To compare the two treatment groups with regard to: patient and graft survival (12 months), biopsy-proven and presumptive rejection episodes (3 and 12 months), posttransplant (12 months) incidence and severity of hypertension, hyperlipidemia, glucose intolerance, incidence of infection and tolerability and “success rate” of TDM guided CellCept® dosing in a calcineurin inhibitor-free immunosuppressive protocol over 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00138970
|Principal Investigator:||Anders Hartmann, MD||Rikshospitalet, Section of Nephrology|