drugset / Trial / NCT01560572
Steroid Free Immunosuppression or Calcineurin Inhibitor Minimization After Basiliximab Induction Therapy in Kidney Transplantation: Comparison With a Standard Quadruple Immunosuppressive Regimen
Phase 4
Completed
305 enrolled
University Medical Center Groningen
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · collabLeiden University Medical Center · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A prospective, open, randomized trial, in which the investigators aim to achieve optimal immunosuppression after renal renal transplantation with maximal reduction of side effects, especially of vascular injury, chronic allograft nephropathy, osteoporosis and malignancies. Immunosuppression without steroids and CNI minimization is compared to standard immunosuppression, consisting of tacrolimus OD, mycophenolic acid and corticosteroids.
Timeline
- Start
- 2011-04
- Primary completion
- 2015-04
- Completion
- 2016-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prednisolone | Other / unclassified | 7.5 mg | — |
| Subject | Tacrolimus | Small molecule | — | — |
| Background | mycophenolic acid | Small molecule | 540 mg | — |