Triple Arm, Prospectively Randomized Multi Centre Study Phase IV to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation in Non-risk Patients (Harmony)

NCT00724022 Phase 4 COMPLETED

Current practice of immune suppressive standard therapy after renal transplantation in non-risk patients is a triple therapy consisting of steroids, a calcineurin inhibitor and MMF. The aim of this clinical trial is to combine a reduction of CNI using tacrolimus and a concept of not using steroids in order to establish an immunosuppressive regimen in immunologically non-risk patients that is efficient and causes as few side effects as possible.

Details

Lead sponsor	University Hospital Freiburg
Phase	Phase 4
Status	COMPLETED
Enrolment	600
Start date	2008-06
Completion	2014-07

Conditions

• Disorder Related to Renal Transplantation

Interventions

• Basiliximab, Tacrolimus, MMF, Prednisolon
• Basiliximab, Tacrolimus, MMF
• Tacrolimus, MMF, rATG

Primary outcomes

• Efficacy of immunosuppression measured in rejection rate confirmed by biopsy according to BANFF 97, modified 2005. — one year after transplantation

Countries

Germany