Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Transplantation
Intervention: tacrolimus (Drug); mycophenolate mofetil (Drug); daclizumab (Drug); steroids (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Medical Physician, Study Director, Affiliation: Astellas Pharma Europe
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.
Clinical Details
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 design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint.
Secondary outcome: 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
Detailed description:
Comparing efficacy & safety of steroid withdrawal with tacrolimus, mycophenolate mofetil
(MMF) with induction in children after kidney transplantation.
Eligibility
Minimum age: 2 Years.
Maximum age: 18 Years.
Gender(s): Both.
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.
Locations and Contacts
Bruxelles 1020, Belgium
Leuven 3000, Belgium
Praha 150 06, Czech Republic
Lyon 69437, France
Paris 75935, France
Nantes 44093, France
Heidelberg 69120, Germany
Hannover 30625, Germany
Koeln 50924, Germany
Berlin 13353, Germany
Budapest 1082, Hungary
Petah Tikva 49100, Israel
Milano 20122, Italy
Padova 35128, Italy
Genova 16147, Italy
Rome 00165, Italy
Torino 10126, Italy
Genova 16132, Italy
Warszawa 04-730, Poland
Cluj-napoca 400006, Romania
Cape Town, South Africa
Johannesburg, South Africa
Göteborg 413 45, Sweden
Taipei, Taiwan
Ankara, Turkey
Izmir, Turkey
Newcastle-upon-Tyne NE1 4LP, United Kingdom
Leeds LS9 7TF, United Kingdom
Nottingham NG5 1PB, United Kingdom
London WC1 3JH, United Kingdom
Birmingham B4 6NH, United Kingdom
Manchester M27 4HA, United Kingdom
Bristol BS2 8BJ, United Kingdom
Liverpool L12 2AP, United Kingdom
Glasgow G3 8SJ, United Kingdom
Additional Information
Link to FDA website
Starting date: November 2005
Ending date: February 2009
Last updated: December 26, 2007
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