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

NCT00865137 | Completed Phase 3 DMC

• 2 other identifiers: FG-506E-04-32EudraCT No.: 2005-005714-20
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation

Keywords

Kidney Transplantation; Pharmacokinetics; Tacrolimus modified release; FK506E

Outcome Measures

Primary Outcomes (1)

• Assess pharmacokinetic parameters

  Day 7 and Day 14

Study Arms (1)

1 FK506E

EXPERIMENTAL

Drug: Tacrolimus, modified release

Interventions

Tacrolimus, modified release DRUG

Oral

Also known as: FK506E, MR4, Advagraf, Prograf XL

1 FK506E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Maastricht, 6229 HX, Netherlands

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Central Contact

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 16, 2009
• First Posted: March 19, 2009
• Study Start: September 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 18, 2014

Record last verified: 2014-07

Locations

NL (1)