Clinical trial NCT03689075: Extended Release Versus Immediate Release Tacrolimus Following Renal Allograft Failure to Reduce Allosensitisation
Official title: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Transplant Failure
Allosensitization
Immunosuppression
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: Inclusion Criteria:

1. Able to give informed consent.
2. Male or female, at least 18 years of age.
3. Has renal allograft failure and is due to start haemodialysis therapy or within 28 days following starting dialysis.
4. Has been already activated on the transplant wait list or is undergoing work up to be reactivated on the transplant list.
5. Has no indication for graft nephrectomy at the time of transplant failure.
6. Is receiving an immediate release tacrolimus maintenance immunotherapy regimen at the time of allograft failure.

Exclusion Criteria:

1. Has another functioning organ transplanted (eg. pancreas, liver, cardiac) at the time of kidney allograft failure.
2. Allograft failure within a month of transplant.
3. Patients who are due to receive or receiving peritoneal dialysis following graft failure.
4. Patients with detectable DSA at the time of allograft failure
5. Receiving an extended release preparation of tacrolimus as immunotherapy at the time of graft failure.
6. Requires continuation of maintenance immunosuppression other than prednisolone or tacrolimus (eg. Mycophenolate mofetil or sirolimus).
7. Patients who on IR-FK conversion would require less than 0.75mg of Envarsus.
8. HLA type of donor is unknown.
9. Has a history of, or active co-morbidity that in the Investigator's opinion, could affect the conduct of the study.
10. Has any condition at the time of recruitment which would prohibit or pose a relative contraindication for the continued use of tacrolimus to a target trough level of between 3-5ng/ml
11. Active bacterial, viral (including CMV and EBV) or parasitic infections, including tuberculosis that, in the Investigator's opinion, could affect the conduct of the study.
12. Has active malignancy.
13. Female patients of child bearing age, who wish to consider pregnancy.

Primary outcomes:
measure: Incidence of de novo allosensitisation (donor specific antibodies) at 24 months post allograft failure.
timeFrame: 24 months
Secondary outcomes:
measure: Medication adherence measurement
timeFrame: 24 months
measure: Health-Related Quality of Life measurement
timeFrame: 24 months
measure: Coefficient of variation of tacrolimus levels at 24 months post allograft failure.
timeFrame: 24 months
measure: Adverse events
timeFrame: 24 months
measure: Chances of re-transplantation as determined by the transplant matchability calculator available from NHSBT
timeFrame: 24 months
measure: Proportion of patients retransplanted during the study period
timeFrame: 24 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
References: