Tacrolimus monitoring in renal transplantation
Research type
Research Study
Full title
Tacrolimus monitoring in renal transplantation
IRAS ID
166579
Contact name
Jennifer Joslin
Contact email
Sponsor organisation
St George’s University of London
Duration of Study in the UK
0 years, 0 months, 19 days
Research summary
Tacrolimus is the most widely-used immunosuppressant drug in new renal transplant recipients in the United Kingdom. There is substantial variation between individuals in the blood drug concentration achieved by a given dose.
The concentration of tacrolimus in whole blood is routinely measured after transplantation as a guide to dose adjustment (therapeutic drug monitoring). Patients can experience rejection if levels are too low, and toxicity if levels are too high.
Risk of rejection is greatest soon after transplantation, and levels are monitored frequently and doses adjusted accordingly in the first few months. However, although there is evidence that a lower target range is indicated later after transplant, there are no published guidelines suggesting how frequently tacrolimus should be measured. Further, tacrolimus levels can vary in the same individual depending on other variable factors, including concomitant medication, and there are no guidelines regarding how many samples should be taken before adjusting the dose in this later period.This study will look at the cohort of patients under the care of St George’s Renal Unit who have had their renal transplant for more than one year, and review how frequently they have had their tacrolimus levels measured and the effect that taking the these measurements had on their dosing regimes.
By understanding the value of these historic tacrolimus measurements it is hoped that we will be able to propose a more useful measuring regime for future patients.
REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/2038
Date of REC Opinion
24 Nov 2014
REC opinion
Favourable Opinion