Who is sponsoring NCT00138970?

NCT00138970 is sponsored by University of Oslo School of Pharmacy.

What condition does NCT00138970 study?

NCT00138970 studies Renal Transplant Recipients.

What drugs are being tested in NCT00138970?

Interventions: Zenapax®, CellCept® and prednisolone, Sandimmun Neoral®, CellCept® and prednisolone.

What is the status of NCT00138970?

NCT00138970 is currently COMPLETED.

Last reviewed 2005-11-30 · How we verify

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

NCT00138970 Phase 4 COMPLETED

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.

Details

Lead sponsor	University of Oslo School of Pharmacy
Phase	Phase 4
Status	COMPLETED
Enrolment	70
Start date	2002-01
Completion	2005-02

Conditions

Renal Transplant Recipients

Interventions

Zenapax®, CellCept® and prednisolone
Sandimmun Neoral®, CellCept® and prednisolone

Primary outcomes

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.