A study to compare slow release (only required once day) versus fast release (needed to be taken twice a day) tacrolimus to reduce the risk of new antibodies forming against a failed transplant in patients on dialysis who are awaiting further transplantatio

Phase 1

• Conditions: Transplant rejection following transplant failure and return to dialysis (transplant rejection defined as the development of new HLA antibodies against the transplant); MedDRA version: 20.0 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection System Organ Class: 100000004865; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-000652-18-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-18
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 64

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 live.
5.Has no indication at the time of transplant failure for graft nephrectomy.
6.Is receiving an immediate release tacrolimus maintenance immunotherapy regimen at the time of allograft failure.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

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 transplantation.
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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified