Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation
TWIST
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
2 other identifiers
interventional
198
14 countries
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2005
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 23, 2006
CompletedFirst Posted
Study publicly available on registry
February 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedJune 26, 2015
June 1, 2015
2.3 years
February 23, 2006
June 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint.
6 months
Secondary Outcomes (1)
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
Study Arms (2)
1
ACTIVE COMPARATOR2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Unknown Facility
Brussels, 1020, Belgium
Unknown Facility
Leuven, 3000, Belgium
Unknown Facility
Prague, 150 06, Czechia
Unknown Facility
Lyon, 69437, France
Unknown Facility
Nantes, 44093, France
Unknown Facility
Paris, 75935, France
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Berlin, 13353, Germany
Unknown Facility
Cologne, 50924, Germany
Unknown Facility
Hanover, 30625, Germany
Unknown Facility
Heidelberg, 69120, Germany
Unknown Facility
Budapest, 1082, Hungary
Unknown Facility
Petah Tikva, 49100, Israel
Unknown Facility
Genova, 16132, Italy
Unknown Facility
Genova, 16147, Italy
Unknown Facility
Milan, 20122, Italy
Unknown Facility
Padua, 35128, Italy
Unknown Facility
Rome, 00165, Italy
Unknown Facility
Torino, 10126, Italy
Unknown Facility
Warsaw, 04-730, Poland
Unknown Facility
Cluj-Napoca, 400006, Romania
Unknown Facility
Cape Town, South Africa
Unknown Facility
Johannesburg, South Africa
Unknown Facility
Gothenburg, 413 45, Sweden
Unknown Facility
Taipei, Taiwan
Unknown Facility
Ankara, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Birmingham, B4 6NH, United Kingdom
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Bristol, BS2 8BJ, United Kingdom
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Glasgow, G3 8SJ, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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Liverpool, L12 2AP, United Kingdom
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London, WC1 3JH, United Kingdom
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Manchester, M27 4HA, United Kingdom
Unknown Facility
Newcastle upon Tyne, NE1 4LP, United Kingdom
Unknown Facility
Nottingham, NG5 1PB, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Physician
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2006
First Posted
February 27, 2006
Study Start
November 1, 2005
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
June 26, 2015
Record last verified: 2015-06