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

Phase 4

• Conditions: Kidney Transplant Failure; Immunosuppression; Allosensitization
• Interventions: Drug: Envarsus Oral Product

• Registration Number: NCT03689075
• Lead Sponsor: Imperial College London

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-28
• Study Start: 2018-11-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-02-28
• Primary Completion: 2021-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extended release tacrolimus	Envarsus Oral Product	-

Primary Outcome Measures

Name	Time	Method
Incidence of de novo allosensitisation (donor specific antibodies) at 24 months post allograft failure.	24 months	Number of patients who develop new DSA in each group

Secondary Outcome Measures

Name	Time	Method
Coefficient of variation of tacrolimus levels at 24 months post allograft failure.	24 months	Incorporating all study visit trough tacrolimus levels (standard deviation/mean)
Medication adherence measurement	24 months	Will be measured by BAASIS questionnaire (comparison of scores)
Adverse events	24 months	Incidence of infective episodes, malignancy, diabetes, erythropoietin resistance, graft nephrectomy
Health-Related Quality of Life measurement	24 months	Will be measured by the EQ-5D-5L Questionnaire (comparison of scores) - 5D; - 5L Questionnaire
Chances of re-transplantation as determined by the transplant matchability calculator available from NHSBT	24 months	Will be calculated by using the NHSBT calculator
Proportion of patients retransplanted during the study period	24 months	Proportion of patients in each arm receiving a transplant

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom