MITRA Study
Research type
Research Study
Full 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
IRAS ID
240710
Contact name
Varuna Aluvihare
Contact email
Sponsor organisation
Astellas Pharma Europe Ltd.
Eudract number
2017-004121-33
Clinicaltrials.gov Identifier
2017-004121-33, European Clinical Trials Database (EudraCT) number
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
This research project is looking at a new test method for assessing the levels of the drug tacrolimus (also known as Advagraf) in the blood of organ transplant recipients, which is a key component of post-transplant care for these patients. It aims to compare tacrolimus levels assessed using the new 'MITRA' method (using blood collected in a MITRA blood sample device, that enables the collection of a small volume of blood from a finger prick with high precision) with drug levels assessed using the normal assessment method currently used in standard practice (i.e. blood taken from a vein using a needle).
40 liver and 40 kidney adult transplant recipient patients will be recruited in total across four centres (two centres in the UK and two in France). For each patient, a pair of samples (one collected using the MITRA device and one via the standard needle blood draw) will be collected at 3 time points: prior to the daily Advagraf dose and at 1 and 3 hours post-dose, which will then be shipped to a central laboratory for assessment and comparison of the detected drug levels.
This is not a drug study nor a device study, but is looking at the assessment of blood drug levels provided by the MITRA method compared to the standard blood sample assessment method to ensure they are comparable. No intervention is proposed to the participants' ongoing clinical care and no drug therapy treatment is provided or changed as part of this study.
In the future, it is hoped that this newly developed technique could be used to allow patients to take blood samples at home and post them directly to the laboratory, instead of needing to attend hospital for routine blood samples.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
18/SC/0094
Date of REC Opinion
7 Feb 2018
REC opinion
Favourable Opinion