An Open Study Assessing Bioavailability of a Modified Formulation of Tacrolimus in Kidney Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT00865137|
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : July 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation||Drug: Tacrolimus, modified release||Phase 3|
Stable kidney transplant recipients who are participating in the clinical trial FG-506-14-02 and who are currently being treated with FK506E (MR4) under fasted conditions and who have had no changes in any of their medications for at least seven days will be enrolled in the sub-study. Following enrolment, all patients will remain on all their medication and the same dosing regimen throughout the study.During the study two 24 hour blood concentration time profiles will be collected, each one on the last day of Period 2 and Period 3 of the sub-study as follows:
Profile 1 on Day 7 under fasted conditions
Profile 2 on Day 14 under non-fasted conditions
A total of five scheduled visits are planned.
At least 24 patients with two complete, evaluable profiles are needed to estimate the effect of food on the oral bioavailability of FK506E (MR4).
Blood sampling - For each sample a 2 mL aliquot of whole blood will be collected. The total blood volume for the two profiles taken per patient will be approximately 40 mL.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single-centre Study to Assess the Effect of Food on the Relative Bioavailability of Orally Administered Tacrolimus Modified Release Formulation, FK506E (MR4), in Stable Kidney Transplant Recipients|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
|Experimental: 1 FK506E||
Drug: Tacrolimus, modified release
- Assess pharmacokinetic parameters [ Time Frame: Day 7 and Day 14 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865137
|Maastricht, Netherlands, 6229 HX|
|Study Director:||Central Contact||Astellas Pharma Europe B.V.|