Extended Release Versus Immediate Release Tacrolimus Following Renal Allograft Failure to Reduce … (NCT03689075) | Clinical Trial Compass
TerminatedPhase 4
Extended Release Versus Immediate Release Tacrolimus Following Renal Allograft Failure to Reduce Allosensitisation
Stopped: Non-feasible due to change in clinical practice
United Kingdom35 participantsStarted 2018-11-01
Plain-language summary
Study to compare once-daily extended release tacrolimus versus twice-daily immediate release tacrolimus following renal allograft failure to reduce the risk of allosensitisation
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Able to give informed consent.
✓. Male or female, at least 18 years of age.
✓. Has renal allograft failure and is due to start haemodialysis therapy or within 28 days following starting dialysis.
✓. Has been already activated on the transplant wait list or is undergoing work up to be reactivated on the transplant list.
✓. Has no indication for graft nephrectomy at the time of transplant failure.
✓. Is receiving an immediate release tacrolimus maintenance immunotherapy regimen at the time of allograft failure.
Exclusion criteria
✕. Has another functioning organ transplanted (eg. pancreas, liver, cardiac) at the time of kidney allograft failure.
✕. Allograft failure within a month of transplant.
✕. Patients who are due to receive or receiving peritoneal dialysis following graft failure.
✕. Patients with detectable DSA at the time of allograft failure
✕. Receiving an extended release preparation of tacrolimus as immunotherapy at the time of graft failure.
✕. Requires continuation of maintenance immunosuppression other than prednisolone or tacrolimus (eg. Mycophenolate mofetil or sirolimus).
What they're measuring
1
Incidence of de novo allosensitisation (donor specific antibodies) at 24 months post allograft failure.