NCT00296348

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

An Open, Randomised, Multicentre Clinical Study to Investigate the Safety and Efficacy of Steroid Withdrawal With Tacrolimus, Mycophenolate Mofetil and Daclizumab Against Tacrolimus, Mycophenolate Mofetil and Steroids in Children After Kidney Transplantation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Comparing efficacy \& safety of steroid withdrawal with tacrolimus, mycophenolate mofetil (MMF) with induction in children after kidney transplantation.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	tacrolimus	immunosuppression
DRUG	mycophenolate mofetil	oral
DRUG	daclizumab	oral
DRUG	steroids	oral

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2006-02-27
• Last updated: 2015-06-26

Locations

35 sites across 14 countries: Belgium, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Romania, South Africa, Sweden, Taiwan, Turkey (Türkiye), United Kingdom