Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation
NCT ID: NCT00296348
Last Updated: 2015-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
198 participants
INTERVENTIONAL
2005-11-30
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
tacrolimus
immunosuppression
mycophenolate mofetil
oral
steroids
oral
2
tacrolimus
immunosuppression
mycophenolate mofetil
oral
daclizumab
oral
Interventions
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tacrolimus
immunosuppression
mycophenolate mofetil
oral
daclizumab
oral
steroids
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
2 Years
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Physician
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
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Bristol, , United Kingdom
Glasgow, , United Kingdom
Leeds, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Nottingham, , United Kingdom
Brussels, , Belgium
Leuven, , Belgium
Prague, , Czechia
Lyon, , France
Nantes, , France
Paris, , France
Berlin, , Germany
Cologne, , Germany
Hanover, , Germany
Heidelberg, , Germany
Budapest, , Hungary
Petah Tikva, , Israel
Genova, , Italy
Genova, , Italy
Milan, , Italy
Padua, , Italy
Rome, , Italy
Torino, , Italy
Warsaw, , Poland
Cluj-Napoca, , Romania
Cape Town, , South Africa
Johannesburg, , South Africa
Gothenburg, , Sweden
Taipei, , Taiwan
Ankara, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Birmingham, , United Kingdom
Countries
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Related Links
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Link to FDA website
Link to Results on EudraCT
Other Identifiers
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PRG-EC-0243
Identifier Type: OTHER
Identifier Source: secondary_id
FG-506-02-43
Identifier Type: -
Identifier Source: org_study_id
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