SHIRE AMR PRO & QoL
Research type
Research Study
Full title
An observational, cross-sectional study to assess the Quality of Life (QoL) of kidney transplant patients with acute anti-body mediated rejection (AMR)
IRAS ID
238775
Contact name
Titus Augustine
Contact email
Sponsor organisation
Shire Pharmaceuticals Inc
Duration of Study in the UK
0 years, 10 months, 20 days
Research summary
This international, cross-sectional, matched cohort study is designed to provide current individual data values and population distributions for measurements of Quality of Life (QoL) and Health Utility (HU) of patients who have or have not experienced antibody-mediated rejection (AMR) following renal transplantation.
The study will be conducted in one selected site in each of 4 countries (U.S., Canada, U.K. and Germany), and will enroll approximately 50 participants per site for a total of 200 participants. Graft function will be divided into 5 functional strata, corresponding to chronic kidney disease (CKD) Stage 2 to Stage 5 determined by estimated glomerular filtration rate (GFR). A total of 10 participants with stable function will be enrolled into each functional stratum in each site,comprising approximately 5 participants with AMR and 5 participants without AMR matched for
graft function, time post-transplant, recipient age and presence of diabetes mellitus.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
18/NE/0081
Date of REC Opinion
5 Apr 2018
REC opinion
Favourable Opinion