Optimized TacrolimuS and MMF for HLA Antibodies after Renal Transplantatio

Not Applicable

Completed

• Conditions: Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal; Injury, Occupational Diseases, Poisoning; Kidney transplant failure and rejection

• Registration Number: ISRCTN46157828
• Lead Sponsor: King's College London (UK)

Brief Summary

2014 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/24447519 protocol 2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31383029 updated protocol and statistical analysis plan (added 07/08/2019) 2016 Abstract results in https://bts.org.uk/wp-content/uploads/2016/09/BTS_Abstract_pdf_2016.pdf (added 18/11/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36684392/ (added 24/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-26
• Study Completion: 2020-09-30
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2037

Inclusion Criteria

1. Renal transplant recipients >1 year post transplantation
2. Aged 18-70 years, male and female
3. Estimated glomerular filtration rate (eGFR) of >=30

Exclusion Criteria

1. Recipient requiring HLA desensitisation to remove antibody for a positive XM transplant
2. Recipient known already to have HLA antibody who has received specific intervention for that antibody or for CAMR / chronic rejection
3. Recipient of additional solid organ transplants (e.g. pancreas, heart, etc).
4. History of malignancy in previous 5 years (excluding non-melanomatous tumours limited to skin)
5. HBsAg+,HBcAb+, HepC+ or HIV+ recipient (on test performed within previous 5 years)
6. History of acute rejection requiring escalation of immunosuppression in the 6 months prior to screening.
7. History of an ongoing or previous infection (no time limit) that would prevent optimization of immunosuppression, including ocular Herpes simplex.
8. Known hypersensitivity to any of the IMPs
9. Known hereditary disorders of carbohydrate metabolism
10. Patient enrolled in any other studies involving administration of another IMP at time of recruitment
11. Pregnancy or breastfeeding females (based on verbal history of recipient)
12. Pre-menopausal females who refuse to consent to using suitable methods of contraception throughout the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 12/05/2020:<br> Determine the time to graft failure in patients testing positive for HLA Ab at baseline or within 32 months of randomization who receive an optimized anti-rejection medication intervention with prednisone, Tac and MMF (‘treatment’), compared to a control group who test positive for HLA Ab at baseline or within 32 months post-randomization who remain on their established immunotherapy and whose clinicians are not aware of their Ab status. The primary endpoint will be assessed remotely when a minimum of 43 months post-randomisation has been achieved by all.<br><br> Previous primary outcome measure:<br> Renal Transplant Failure Rates; Timepoint(s): 3 Years post-recruitment<br>