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

NCT03689075 | Terminated Phase 4

• 1 other identifier: 18IC4423
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Kidney Transplant Failure; Allosensitization; Immunosuppression

Outcome Measures

Primary Outcomes (1)

• Incidence of de novo allosensitisation (donor specific antibodies) at 24 months post allograft failure.

  Number of patients who develop new DSA in each group

  24 months

Secondary Outcomes (6)

• Medication adherence measurement

  24 months

• Health-Related Quality of Life measurement

  24 months

• Coefficient of variation of tacrolimus levels at 24 months post allograft failure.

  24 months

• Adverse events

  24 months

• Chances of re-transplantation as determined by the transplant matchability calculator available from NHSBT

  24 months

Study Arms (2)

Immediate release tacrolimus

NO INTERVENTION

Patients will continue on immediate release tacrolimus

Extended release tacrolimus

ACTIVE COMPARATOR

Drug: Envarsus Oral Product

Interventions

Envarsus Oral Product DRUG

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

Extended release tacrolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Patients who on IR-FK conversion would require less than 0.75mg of Envarsus.
• HLA type of donor is unknown.
• Has a history of, or active co-morbidity that in the Investigator's opinion, could affect the conduct of the study.
• 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
• 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.
• Has active malignancy.
• Female patients of child bearing age, who wish to consider pregnancy.

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 28, 2018
• Study Start: November 1, 2018
• Primary Completion: June 27, 2024
• Study Completion: February 25, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)