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

• Sponsor: Imperial College London (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03689075
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated 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: Nov 1, 2018
• Anticipated Primary Completion Date: Nov 1, 2021
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Medication adherence measurement [24 months]

   Will be measured by BAASIS questionnaire (comparison of scores)

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

   Incorporating all study visit trough tacrolimus levels (standard deviation/mean)

4. Adverse events [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 [24 months]

   Will be calculated by using the NHSBT calculator

6. Proportion of patients retransplanted during the study period [24 months]

   Proportion of patients in each arm receiving a transplant

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Imperial College Healthcare NHS Trust	London		United Kingdom	W12 0HS

Sponsors and Collaborators

• Imperial College London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT03689075
• Other Study ID Numbers: 18IC4423
• First Posted: Sep 28, 2018
• Last Update Posted: Feb 28, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tacrolimus

Study Results

No Results Posted as of Feb 28, 2019