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Non-feasible due to change in clinical practice
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Study to compare once-daily extended release tacrolimus versus twice-daily immediate release tacrolimus following renal allograft failure to reduce the risk of allosensitisation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate release tacrolimus | No Intervention | Patients will continue on immediate release tacrolimus | |
| Extended release tacrolimus | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Envarsus Oral Product | Drug | Patients will be randomised to receive either envarsus or to continue on an immediate release tacrolimus formulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of de novo allosensitisation (donor specific antibodies) at 24 months post allograft failure. | Number of patients who develop new DSA in each group | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence measurement | Will be measured by BAASIS questionnaire (comparison of scores) | 24 months |
| Health-Related Quality of Life measurement | Will be measured by the EQ-5D-5L Questionnaire (comparison of scores) - 5D - 5L Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |
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| 24 months |
| Coefficient of variation of tacrolimus levels at 24 months post allograft failure. | Incorporating all study visit trough tacrolimus levels (standard deviation/mean) | 24 months |
| Adverse events | Incidence of infective episodes, malignancy, diabetes, erythropoietin resistance, graft nephrectomy | 24 months |
| Chances of re-transplantation as determined by the transplant matchability calculator available from NHSBT | Will be calculated by using the NHSBT calculator | 24 months |
| Proportion of patients retransplanted during the study period | Proportion of patients in each arm receiving a transplant | 24 months |