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

Phase 3

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: tacrolimus; Drug: mycophenolate mofetil; Drug: steroids; Drug: daclizumab

• Registration Number: NCT00296348
• Lead Sponsor: Astellas Pharma Inc

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 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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-02-23
• Study First Submitted QC: 2006-02-23
• Study First Posted: 2006-02-27
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	steroids	-
1	tacrolimus	-
1	mycophenolate mofetil	-
2	tacrolimus	-
2	mycophenolate mofetil	-
2	daclizumab	-

Primary Outcome Measures

Name	Time	Method
Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint.	6 months

Secondary Outcome Measures

Name	Time	Method
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