A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients
NCT ID: NCT00282243
Last Updated: 2013-09-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2003-02-28
2008-10-31
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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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Tacrolimus MR
After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.
Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons.
tacrolimus modified release (MR)
Oral
tacrolimus
Oral
Interventions
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tacrolimus modified release (MR)
Oral
tacrolimus
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient has stable whole blood trough level concentrations of Prograf® and is clinically stable
Exclusion Criteria
* Patient is currently receiving sirolimus immunosuppression therapy.
18 Years
65 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma US, Inc.
Locations
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Palo Alto, California, United States
Denver, Colorado, United States
Baltimore, Maryland, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
New York, New York, United States
Cincinnati, Ohio, United States
Dallas, Texas, United States
Madison, Wisconsin, United States
Countries
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References
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Florman S, Alloway R, Kalayoglu M, Punch J, Bak T, Melancon J, Klintmalm G, Busque S, Charlton M, Lake J, Dhadda S, Wisemandle K, Wirth M, Fitzsimmons W, Holman J, First MR. Once-daily tacrolimus extended release formulation: experience at 2 years postconversion from a Prograf-based regimen in stable liver transplant recipients. Transplantation. 2007 Jun 27;83(12):1639-42. doi: 10.1097/01.tp.0000265445.09987.f1.
Florman S, Alloway R, Kalayoglu M, Lake K, Bak T, Klein A, Klintmalm G, Busque S, Brandenhagen D, Lake J, Wisemandle K, Fitzsimmons W, First MR. Conversion of stable liver transplant recipients from a twice-daily Prograf-based regimen to a once-daily modified release tacrolimus-based regimen. Transplant Proc. 2005 Mar;37(2):1211-3. doi: 10.1016/j.transproceed.2004.11.086.
Other Identifiers
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02-0-152
Identifier Type: -
Identifier Source: org_study_id