Clinical trial NCT00296348: Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Keywords: Tacrolimus
Kidney Transplantation
Child
Treatment Outcome
Immunosuppression
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-02-27
Enrollment: 198
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint.
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
city: Leuven
country: Belgium
city: Praha
country: Czech Republic
city: Lyon
country: France
city: Nantes
country: France
city: Paris
country: France
city: Berlin
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Koeln
country: Germany
city: Budapest
country: Hungary
city: Petah Tikva
country: Israel
city: Genova
country: Italy
city: Genova
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Rome
country: Italy
city: Torino
country: Italy
city: Warszawa
country: Poland
city: Cluj-napoca
country: Romania
city: Cape Town
country: South Africa
city: Johannesburg
country: South Africa
city: Göteborg
country: Sweden
city: Taipei
country: Taiwan
city: Ankara
country: Turkey
city: Izmir
country: Turkey
city: Birmingham
country: United Kingdom
city: Bristol
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Leeds
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Newcastle-upon-Tyne
country: United Kingdom
city: Nottingham
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Medical Physician
role: STUDY_DIRECTOR
References: