Kidney Transplant FailurePhase 4EVITRANCT03689075
Extended Release Versus Immediate Release Tacrolimus Following Renal Allograft Failure to Reduce Allosensitisation
A Phase 4 study testing Envarsus Oral Product in people with Kidney Transplant Failure and Allosensitization, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Failure, Allosensitization, Immunosuppression
- What is being tested?
- Envarsus Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2018to 25 Feb 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
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 to compare once-daily extended release tacrolimus versus twice-daily immediate release tacrolimus following renal allograft failure to reduce the risk of allosensitisation
- Being tested
- Envarsus Oral Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Envarsus Oral ProductDrug
Patients will be randomised to receive either envarsus or to continue on an immediate release tacrolimus formulation
| Study group | Role | What they receive |
|---|---|---|
| Immediate release tacrolimus | No intervention | Patients will continue on immediate release tacrolimus |
| Extended release tacrolimus | Active comparator | Not described Receives: Drug: Envarsus Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of de novo allosensitisation (donor specific antibodies) at 24 months post allograft failure.
Number of patients who develop new DSA in each group
Measured: 24 months
Secondary outcomes (6)
Medication adherence measurement
Will be measured by BAASIS questionnaire (comparison of scores)
Measured: 24 months
Health-Related Quality of Life measurement
Will be measured by the EQ-5D-5L Questionnaire (comparison of scores) - 5D
- 5L Questionnaire
Measured: 24 months
Coefficient of variation of tacrolimus levels at 24 months post allograft failure.
Incorporating all study visit trough tacrolimus levels (standard deviation/mean)
Measured: 24 months
Adverse events
Incidence of infective episodes, malignancy, diabetes, erythropoietin resistance, graft nephrectomy
Measured: 24 months
Chances of re-transplantation as determined by the transplant matchability calculator available from NHSBT
Will be calculated by using the NHSBT calculator
Measured: 24 months
Proportion of patients retransplanted during the study period
Proportion of patients in each arm receiving a transplant
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start1 Nov 2018
- Primary completion27 Jun 2024
- Study completion25 Feb 2025
Why it stopped: Non-feasible due to change in clinical practice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689075
- Sponsor's protocol ID
- 18IC4423
- Acronym
- EVITRA
- Status last verified
- Apr 2025
- First submitted
- 20 Sep 2018
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03689075
- Acronym / sponsor ID
- EVITRA / 18IC4423
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Non-feasible due to change in clinical practice
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate release tacrolimus | No intervention | –Patients will continue on immediate release tacrolimus |
| Extended release tacrolimus | Active comparator | Drug: Envarsus Oral Product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Envarsus Oral ProductPatients will be randomised to receive either envarsus or to continue on an immediate release tacrolimus formulation | Drug | Extended release tacrolimus |
Primary outcome
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
6 secondary outcomes
Medication adherence measurement
Time frame: 24 months
Health-Related Quality of Life measurement
Time frame: 24 months
Coefficient of variation of tacrolimus levels at 24 months post allograft failure.
Time frame: 24 months
Adverse events
Time frame: 24 months
Chances of re-transplantation as determined by the transplant matchability calculator available from NHSBT
Time frame: 24 months
Proportion of patients retransplanted during the study period
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Non-feasible due to change in clinical practice). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Envarsus Oral Product in people with Kidney Transplant Failure and Allosensitization, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Non-feasible due to change in clinical practice). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of de novo allosensitisation (donor specific antibodies) at 24 months post allograft failure. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.