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 个研究点目标入组 2,037 人开始时间: 2013年3月26日最近更新: 2023年2月6日

适应症

试验速览

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)

•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.

发起方

King's College London (UK)