drugset / Trial / NCT00296348
Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation
RandomizedParallel-groupOpen-labelPrevention
Summary
The primary objective of this study is to investigate the impact of early corticosteroid withdrawal in paediatric renal transplant patients on growth expressed as change in height standard deviation score (SDS) from baseline to end of study as the primary endpoint. The expected advantages are reduced growth suppression, lower incidence of arterial hypertension and post transplant diabetes mellitus (PTDM) and improved lipid metabolism, expressed by lower serum lipid values.
Timeline
- Start
- 2005-11
- Primary completion
- 2008-02
- Completion
- 2008-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daclizumab | Monoclonal antibody | — | Oral |
| Background | Mycophenolate Mofetil | Small molecule | — | Oral |
| Background | Tacrolimus | Small molecule | — | — |
Indications
No indication recorded.