A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Kidney Transplant Recipients
NCT ID: NCT00717678
Last Updated: 2015-12-17
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
73 participants
INTERVENTIONAL
2007-12-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prograf-XL + MMF
Prograf-XL
oral
MMF
oral
Prograf + MMF
Prograf
oral
MMF
oral
Interventions
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Prograf-XL
oral
Prograf
oral
MMF
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living kidney transplant
* Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure
* Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization
Exclusion Criteria
* Patient has received a kidney transplant from a non-heart beating donor
* Patient has received an ABO incompatible donor kidney
* Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
* Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
* Patient has significant liver disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
* Patient has an uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives
* Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
* Patient is receiving everolimus or enteric coated mycophenolic acid at any time during the study
* Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil or corticosteroids
* Patient is pregnant or lactating
* Patient is unlikely to comply with the visits scheduled in the protocol
* Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator
12 Years
ALL
No
Sponsors
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Astellas Pharma Taiwan, Inc.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Countries
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Related Links
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Link to results on Astellas Clinical Study Results Web site
Other Identifiers
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PRGXLKTx-0701-TW
Identifier Type: -
Identifier Source: org_study_id