Overview

Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation

Status:
Completed

Trial end date:
2008-02-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Astellas Pharma Inc

Treatments:

Daclizumab
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus