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

Study Overview
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Brief Summary
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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.

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

Official Title
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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

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: tacrolimus
* Drug: mycophenolate mofetil
* Drug: daclizumab
* Drug: steroids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: tacrolimus<br>* immunosuppression<br>* Other names: FK506;Drug: mycophenolate mofetil<br>* oral<br>* Other names: MMF;Drug: steroids<br>* oral<br>|
| Experimental: 2<br> | Drug: tacrolimus<br>* immunosuppression<br>* Other names: FK506;Drug: mycophenolate mofetil<br>* oral<br>* Other names: MMF;Drug: daclizumab<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tacrolimus, Kidney Transplantation, Child, Treatment Outcome, Immunosuppression