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

Immunosuppression Clinical Trial

— EVITRA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03689075
• Other study ID #: 18IC4423
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2018
• Est. completion date: November 2023

Study information

• Verified date: February 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: November 2023
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allosensitization
• Immunosuppression
• Kidney Transplant Failure

Intervention

Drug:
• Envarsus Oral Product
Patients will be randomised to receive either envarsus or to continue on an immediate release tacrolimus formulation

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

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