A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients
NCT ID: NCT00384137
Last Updated: 2014-07-09
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
128 participants
INTERVENTIONAL
2006-10-31
2007-07-31
Brief Summary
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Detailed Description
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Six weeks Prograf-Treatment Phase to confirm compliance to regimen stability requirements (see Inclusion and Exclusion Criteria), and collection of data under Prograf treatment.
Conversion from Prograf (twice daily, morning \& evening dosing) total daily dose to MR4 once daily (only morning dosing) on a 1:1 (mg:mg) basis on Day 1.
Twelve weeks MR4-Treatment Phase with study assessments for safety and efficacy.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Tacrolimus
Immunosuppression
Interventions
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Tacrolimus
Immunosuppression
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prograf® dose remained unchanged for a minimum of 12 weeks prior to enrollment and tacrolimus whole blood trough level measurements were in the range of 5-15 ng/mL.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Astellas Pharma Europe BV
Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma GmbH
Locations
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Bicêtre, , France
Freiburg im Breisgau, , Germany
Regensburg, , Germany
Maastricht, , Netherlands
Rotterdam, , Netherlands
Poznan, , Poland
Szczecin, , Poland
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Manchester, , United Kingdom
Countries
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Other Identifiers
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PMR-EC-1205
Identifier Type: -
Identifier Source: org_study_id
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