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NCT03465969 Clinical Trial

A Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients

Kidney Transplantation Clinical Trial

— MITRA  

Official title:
A Bioanalytical Method Cross-validation Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03465969
Other study ID # 506-MA-3189
Secondary ID 2017-004121-33
Status Completed
Phase Phase 4
First received
Last updated
Start date March 20, 2018
Est. completion date September 14, 2018

Study information
Verified date October 2018
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

This will be a bioanalytical assay method cross-validation study using blood samples donated by liver or kidney transplant participants. Participants will have been on a stable dose of Advagraf and deemed clinically stable for a period of 3-6 months and attend a routine out-patient follow-up visit to receive their usual oral dose of commercial Advagraf. Participants will be asked to provide 1 whole blood venepuncture sample and 1 whole blood finger prick MITRA sample at pre-dose and at approximately 1 and 3 hours post-dose. Participants will be kept at the study site for an extra 1 hour to ensure post-sampling safety and will be discharged thereafter.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date September 14, 2018
Est. primary completion date September 14, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• tacrolimus
oral

Locations
Country Name City State
France Site FR33002 Toulouse
France Site FR33001 Villejuif
United Kingdom Site UK44002 Cambridge
United Kingdom Site UK44001 London

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Europe Ltd.

Countries where clinical trial is conducted

France,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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