Japanese study of the effects of AMG (α1-microglobulin) reduction rates on survival (JAMREDS): protocol of a multicenter prospective observational cohort study.

INTRODUCTION:Recent advances in dialysis therapy have made it possible to remove middle molecules. Removal of small-middle molecules, such as β2-microglobulin (BMG), can now be achieved with conventional hemodialysis, and removal of large-middle molecules has become a target, particularly for 1-microglobulin (AMG, 33 kD). The AMG reduction rate has emerged as a target for improvement of various clinical symptoms, but the effects on prognosis have yet to be determined. The "Japanese study of the effects of AMG (α1-microglobulin) reduction rates on survival" (JAMREDS) was started in April 2020, with the goal of determining if the AMG reduction rate associates with the risk of mortality and cardiovascular disease (CVD) events. METHODS:JAMREDS is a prospective observational study in patients on hemodialysis (HD) to examine the effects of: 1) AMG reduction rate on survival outcome and CVD events; 2) dialysis treatment modalities (HD, intermittent infusion hemodiafiltration (iHDF), pre/post-dilution online HDF) on survival and CVD events (based on AMG reduction rates with treatment mode); and 3) AMG reduction rates on survival and CVD events in patients undergoing each therapy (iHDF, pre/post-dilution online HDF). The number of planned subjects was 4000 in pre-planning. Data are collected using RED-Cap, which is an EDC system. A total of 9930 patients were enrolled at the beginning of the study at 59 registered facilities. The JAMREDS observation period will continue until the end of 2023, after which the data will be cleaned and confirmed before analysis. CONCLUSION:This study may provide new evidence for the relationship between the amount of removed large-middle molecules (such as AMG) and the mortality and CVD risk. Comparisons with convection volumes will also be of interest. TRIAL REGISTRATION:UMIN000038457. Registered on 1st November, 2019: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043823.