Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation
NCT ID: NCT00204191
Last Updated: 2007-10-19
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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UNKNOWN
PHASE4
300 participants
INTERVENTIONAL
2003-05-31
2007-12-31
Brief Summary
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Detailed Description
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The study has been designed in a fashion as close to the daily clinical practice as possible. Patients are randomized in pairs, receiving kidneys from the same donor, thus avoiding donor-related bias. Those having specific indications or contraindications for one of the study medications were not entered into the study. All other study-related decisions are made only on a clinical basis and according to the standard practice of the center. Patients are followed on the intention-to-treat rule. Cost-effectiveness will be calculated on 12-month treatment for each patient entered into the study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Interventions
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tacrolimus
Eligibility Criteria
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Inclusion Criteria
* Age over 18 years old
* Specific indications or contraindications for cyclosporine or tacrolimus are absent
* Informed consent
Exclusion Criteria
* Specific contraindications for use of cyclosporine or tacrolimus
* Participation in another interventional clinical trial
* Pregnancy or lactation
18 Years
70 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Uniwersytet Mikolaja Kopernika w Toruniu
OTHER
Principal Investigators
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Zbigniew Wlodarczyk, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Klinika Transplantologii, Collegium Medicum UMK Torun
Locations
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Klinika Transplantologii, Szpital Uniwersytecki, ul. M. Sklodowskiej-Curie 9
Bydgoszcz, , Poland
Countries
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Central Contacts
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Other Identifiers
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IDS PL-02-RG-122
Identifier Type: -
Identifier Source: secondary_id
1/25/03
Identifier Type: -
Identifier Source: org_study_id