Extended Release Versus Immediate Release Tacrolimus Following Renal Allograft Failure to Reduce Allosensitisation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2025-02-25

Brief Summary

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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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Detailed Description

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Conditions

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Kidney Transplant Failure Allosensitization Immunosuppression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Immediate release tacrolimus

Patients will continue on immediate release tacrolimus

Group Type NO_INTERVENTION

No interventions assigned to this group

Extended release tacrolimus

Group Type ACTIVE_COMPARATOR

Envarsus Oral Product

Intervention Type DRUG

Patients will be randomised to receive either envarsus or to continue on an immediate release tacrolimus formulation

Interventions

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Envarsus Oral Product

Patients will be randomised to receive either envarsus or to continue on an immediate release tacrolimus formulation

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No