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. - OuTSMART

Kings College London0 个研究点开始时间: 2012年12月10日最近更新: 2013年2月4日

适应症

试验速览

暂无简介。

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

发起方

Kings College London