A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients
NCT ID: NCT00048152
Last Updated: 2016-11-02
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
539 participants
INTERVENTIONAL
2000-12-31
2006-03-31
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
TREATMENT
NONE
Study Groups
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1
Corticosteroids
As prescribed
Neoral
Low dose (target trough level 50-100ng/mL)
Zenapax
2mg/kg iv first dose, then 1mg/kg every 2 weeks
mycophenolate mofetil [CellCept]
1g po bid
2
Corticosteroids
As prescribed
Neoral
Low dose (target trough level 50-100ng/mL)
Zenapax
2mg/kg iv first dose, then 1mg/kg every 2 weeks
mycophenolate mofetil [CellCept]
1g po bid
3
Corticosteroids
As prescribed
Neoral
Standard dose (target trough level 150-300ng/mL)
mycophenolate mofetil [CellCept]
1g po bid
Interventions
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Corticosteroids
As prescribed
Neoral
Low dose (target trough level 50-100ng/mL)
Neoral
Standard dose (target trough level 150-300ng/mL)
Zenapax
2mg/kg iv first dose, then 1mg/kg every 2 weeks
mycophenolate mofetil [CellCept]
1g po bid
Eligibility Criteria
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Inclusion Criteria
* recipients of primary kidney transplant
* single-organ recipients (kidney only)
Exclusion Criteria
* history of malignancy (except localized skin cancer)
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Birmingham, Alabama, United States
San Francisco, California, United States
Gainesville, Florida, United States
Atlanta, Georgia, United States
Livingston, New Jersey, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Falls Church, Virginia, United States
Adelaide, , Australia
Sydney, , Australia
Brussels, , Belgium
Leuven, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Saskatoon, Saskatchewan, Canada
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Hanover, , Germany
Münster, , Germany
Mexico City, , Mexico
Monterrey, , Mexico
Oslo, , Norway
Warsaw, , Poland
Wroclaw, , Poland
Barcelona, , Spain
Barcelona, , Spain
Córdoba, , Spain
Málaga, , Spain
Santander, , Spain
Valencia, , Spain
Gothenburg, , Sweden
Malmo, , Sweden
Birmingham, , United Kingdom
Glasgow, , United Kingdom
Leicester, , United Kingdom
Countries
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Other Identifiers
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M67005
Identifier Type: -
Identifier Source: org_study_id