NCT03465969

Brief Summary

The purpose of this study is to assess relationship between tacrolimus concentrations determined via whole blood MITRA assay method with those determined using the established and validated whole blood venepuncture method using samples taken from liver and kidney transplant participants.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_4

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

March 20, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

February 21, 2018

Last Update Submit

October 12, 2018

Conditions

Kidney TransplantationLiver Transplantation

Keywords

Kidney transplantationA Bioanalytical Method Cross-validationAdvagrafLiver transplantation

Outcome Measures

Primary Outcomes (1)

  • Comparison of blood concentrations of tacrolimus

    Tacrolimus concentrations will be determined from the dried whole blood samples collected via finger prick into MITRA cartridge and in whole blood taken by venipuncture.

    Day 1

Study Arms (1)

Liver or kidney transplant participants of Advagraf

OTHER

Transplant participants will provide 1 whole blood venepuncture sample and 1 whole blood finger prick MITRA sample at pre-dose of participant's usual oral dose of commercial Advagraf and at approximately 1 and 3 hours post-dose.

Drug: tacrolimus

Interventions

tacrolimusDRUG

oral

Also known as: Advagraf
Liver or kidney transplant participants of Advagraf

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject will be a recipient of either a liver or kidney transplant and on a stable dose of commercial Advagraf minimum of 3 months.
  • Subjects will be with clinically stable graft function for at least 3 months.

You may not qualify if:

  • Subjects who are still participating in another clinical study or who have participated in a clinical study involving administration of an investigational drug in the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Site FR33002

Toulouse, France

Location

Site FR33001

Villejuif, France

Location

Site UK44002

Cambridge, United Kingdom

Location

Site UK44001

London, United Kingdom

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Clinical Research Physician

    Astellas Pharma Europe Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2018

First Posted

March 15, 2018

Study Start

March 20, 2018

Primary Completion

September 14, 2018

Study Completion

September 14, 2018

Last Updated

October 15, 2018

Record last verified: 2018-10

Locations

FR(2)GB(2)