An Open Study Assessing Bioavailability of a Modified Formulation of Tacrolimus in Kidney Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00865137
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : July 18, 2014
Information provided by:
Astellas Pharma Inc

Brief Summary:
The purpose of this study is to evaluate the effect of food on the oral bioavailability of tacrolimus modified release (MR4) capsules together with a standard continental breakfast. The objective is to assess the pharmacokinetics and relative bioavailability with and without food.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Tacrolimus, modified release Phase 3

Detailed Description:

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 FK506E Drug: Tacrolimus, modified release
Other Names:
  • FK506E
  • MR4
  • Advagraf
  • Prograf XL

Primary Outcome Measures :
  1. Assess pharmacokinetic parameters [ Time Frame: Day 7 and Day 14 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stable kidney transplant patient aged ≥ 18 years who is participating in clinical trial FG-506-14-02 and is being treated with FK506E (MR4)
  • The total daily dose of each immunosuppressive medication, including FK506E (MR4), or any other concomitant medication has remained unchanged for at least seven days prior to enrolment
  • Patient has a serum creatinine level < 265 μmol/L at enrolment
  • Female patient of childbearing potential must have a negative serum or urine pregnancy test prior to enrolment and must have agreed to practice effective birth control during the study

Exclusion Criteria:

  • Patient had previously received an organ transplant other than kidney
  • Patient with any form of substance abuse, psychiatric disorder or condition which may complicate communication with the investigator
  • Patient had experienced any rejection episode within 90 days prior to enrolment, any rejection episode within the last six months that had required anti-lymphocyte antibody therapy or more than two rejection episodes within the last 12 months
  • Patient has a chronic dysfunction of the kidney
  • Patient had major changes in her/his immunosuppressive regimen within the last three months prior to enrolment
  • Patient has significant liver disease, defined as having elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels (at least two times the upper value of the normal range at the investigational site) during the 28 days prior to enrolment
  • Patient receives insulin therapy
  • Patient requires treatment with medication or substances known to interfere with tacrolimus metabolism or having taken such medication within 28 days prior to enrolment and during participation
  • Patient had any unstable medical condition that could interfere with the study
  • Patient is pregnant or a breast-feeding mother
  • Patient is known to be positive for HIV

Information from the National Library of Medicine

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 identifier (NCT number): NCT00865137

Maastricht, Netherlands, 6229 HX
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Central Contact Astellas Pharma Europe B.V.

Additional Information:
Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV Identifier: NCT00865137     History of Changes
Other Study ID Numbers: FG-506E-04-32
EudraCT No.: 2005-005714-20
First Posted: March 19, 2009    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014

Keywords provided by Astellas Pharma Inc:
Kidney Transplantation
Tacrolimus modified release

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action