A randomized controlled clinical trial to determine if a combined screening /treatment programme can prevent premature failure of renal transplants due to chronic rejection in patients with HLA antibodies

King's College London (UK)0 sites2,037 target enrollmentMarch 26, 2013

Overview

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)

Registry

who.int

Start Date

March 26, 2013

End Date

September 30, 2020

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

King's College London (UK)

•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