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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03689075
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : February 28, 2019
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Kidney Transplant Failure Allosensitization Immunosuppression Drug: Envarsus Oral Product Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
No Intervention: Immediate release tacrolimus
Patients will continue on immediate release tacrolimus
Active Comparator: Extended release tacrolimus Drug: Envarsus Oral Product
Patients will be randomised to receive either envarsus or to continue on an immediate release tacrolimus formulation

Primary Outcome Measures :
  1. Incidence of de novo allosensitisation (donor specific antibodies) at 24 months post allograft failure. [ Time Frame: 24 months ]
    Number of patients who develop new DSA in each group

Secondary Outcome Measures :
  1. Medication adherence measurement [ Time Frame: 24 months ]
    Will be measured by BAASIS questionnaire (comparison of scores)

  2. Health-Related Quality of Life measurement [ Time Frame: 24 months ]

    Will be measured by the EQ-5D-5L Questionnaire (comparison of scores) - 5D

    - 5L Questionnaire

  3. Coefficient of variation of tacrolimus levels at 24 months post allograft failure. [ Time Frame: 24 months ]
    Incorporating all study visit trough tacrolimus levels (standard deviation/mean)

  4. Adverse events [ Time Frame: 24 months ]
    Incidence of infective episodes, malignancy, diabetes, erythropoietin resistance, graft nephrectomy

  5. Chances of re-transplantation as determined by the transplant matchability calculator available from NHSBT [ Time Frame: 24 months ]
    Will be calculated by using the NHSBT calculator

  6. Proportion of patients retransplanted during the study period [ Time Frame: 24 months ]
    Proportion of patients in each arm receiving a transplant

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03689075

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United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W12 0HS
Contact: Michelle Willicombe    02083836641   
Sponsors and Collaborators
Imperial College London
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Responsible Party: Imperial College London Identifier: NCT03689075    
Other Study ID Numbers: 18IC4423
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action