Study to compare once-daily extended release tacrolimus versus twice-daily immediate release tacrolimus following renal allograft failure to reduce the risk of allosensitisation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
35
Patients will be randomised to receive either envarsus or to continue on an immediate release tacrolimus formulation
Imperial College Healthcare NHS Trust
London, United Kingdom
Incidence of de novo allosensitisation (donor specific antibodies) at 24 months post allograft failure.
Number of patients who develop new DSA in each group
Time frame: 24 months
Medication adherence measurement
Will be measured by BAASIS questionnaire (comparison of scores)
Time frame: 24 months
Health-Related Quality of Life measurement
Will be measured by the EQ-5D-5L Questionnaire (comparison of scores) - 5D \- 5L Questionnaire
Time frame: 24 months
Coefficient of variation of tacrolimus levels at 24 months post allograft failure.
Incorporating all study visit trough tacrolimus levels (standard deviation/mean)
Time frame: 24 months
Adverse events
Incidence of infective episodes, malignancy, diabetes, erythropoietin resistance, graft nephrectomy
Time frame: 24 months
Chances of re-transplantation as determined by the transplant matchability calculator available from NHSBT
Will be calculated by using the NHSBT calculator
Time frame: 24 months
Proportion of patients retransplanted during the study period
Proportion of patients in each arm receiving a transplant
Time frame: 24 months
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