A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
NCT ID: NCT00282568
Last Updated: 2013-09-26
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
2002-08-31
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 Modified Release
Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 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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San Diego, California, United States
Miami, Florida, United States
Minneapolis, Minnesota, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Edmonton, Alberta, Canada
Toronto, Ontario, Canada
Countries
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References
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Alloway R, Steinberg S, Khalil K, Gourishankar S, Miller J, Norman D, Hariharan S, Pirsch J, Matas A, Zaltzman J, Wisemandle K, Fitzsimmons W, First MR. Two years postconversion from a prograf-based regimen to a once-daily tacrolimus extended-release formulation in stable kidney transplant recipients. Transplantation. 2007 Jun 27;83(12):1648-51. doi: 10.1097/01.tp.0000264056.20105.b4.
Alloway R, Steinberg S, Khalil K, Gourishankar S, Miller J, Norman D, Hariharan S, Pirsch J, Matas A, Zaltzman J, Wisemandle K, Fitzsimmons W, First MR. Conversion of stable kidney transplant recipients from a twice daily Prograf-based regimen to a once daily modified release tacrolimus-based regimen. Transplant Proc. 2005 Mar;37(2):867-70. doi: 10.1016/j.transproceed.2004.12.222.
Other Identifiers
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02-0-131
Identifier Type: -
Identifier Source: org_study_id