AGe-adapted Benefits of Envarsus Versus Twice-daily Tacrolimus ImmunosuppressioN druGs After Kidney Transplantation

• Status: Unknown status
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The proportion of elderly patients with end-stage kidney disease undergoing renal replacement therapy (RRT) is steadily increasing. Although kidney transplantation remains the optimal RRT of choice, it is clear that older adults have a differential risk versus benefit profile after kidney transplantation compared to younger adults. No age-adapted immunosuppression for older adults has been shown to improve kidney allograft outcomes but recent sub-analyses of clinical trial data has hinted at improved outcomes for older kidney transplant patients receiving Envarsus versus standard twice-daily tacrolimus formulations. This feasibility study will investigate this effect to see whether a full scale randomised controlled trial is warranted and to provide information regarding study feasibility.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Birmingham NHS Foundation Trust
• Treatments: Mycophenolate mofetil; Tacrolimus

Criteria

Inclusion Criteria:

• kidney alone transplant, age ≥60, known sensitivity to tacrolimus

Exclusion Criteria:

• contra-indication to transplantation, multi-organ transplant, aged <60