Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation (TWIST)
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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.
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
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint. [ Time Frame: 6 months ]
Secondary Outcome Measures :
Acute rejection: Incidence of and time to first biopsy proven acute rejection; overall frequency of acute rejections episodes; incidence of and time to first corticosteroid-resistant rejection; severity of biopsy-proven acute rejections (Banff97 criteria [ Time Frame: 6 months ]
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Ages Eligible for Study:
2 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.