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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Daclizumab; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

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.