Status:
COMPLETED
Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Kidney Transplantation
Eligibility:
All Genders
2-18 years
Phase:
PHASE3
Brief 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 s...
Detailed Description
Comparing efficacy \& safety of steroid withdrawal with tacrolimus, mycophenolate mofetil (MMF) with induction in children after kidney transplantation.
Eligibility Criteria
Inclusion
- Male or female patient younger than 18 but not younger than 2 years of age
- Skeletal age of boys \< or = 17, girls \< or = 15 years
- Patient has end stage kidney disease
- Female patient of childbearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control during the study and 6 weeks thereafter.
- The patient, or in case the patient is a minor, the patient's parent(s) or their legal representative, has been fully informed and has given written informed consent
Exclusion
- Patient has a most recently measured panel reactive antibody (PRA) grade of \> or = 50%
- Patient is allergic to or intolerant of study medication
- Patient and/or donor is known to be HIV positive.
- Patient has significant liver disease
- Patient with malignancy or history of malignancy
- Patient has previously received or is receiving an organ transplant other than kidney.
- Patient has been previously enrolled in this study.
- Patient with the relapsing and non-diarrhoeal form of haemolytic uraemic syndrome.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00296348
Start Date
November 1 2005
End Date
February 1 2008
Last Update
June 26 2015
Active Locations (35)
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1
Brussels, Belgium, 1020
2
Leuven, Belgium, 3000
3
Prague, Czechia, 150 06
4
Lyon, France, 69437