Safety and efficacy of remote ischaemic preconditioning in diabetic kidney disease: a pilot randomised, parallel-arm, sham-controlled trial protocol.

Abstract

Diabetic kidney disease (DKD), characterised by rapid progression and poor prognosis, accounts for approximately 50% of all end-stage renal disease. Remote ischaemic preconditioning (RIP) can reduce the impact of subsequent fatal ischaemic events through brief episodes of ischaemia remote from a target organ. Therefore, we aim to determine whether RIP can slow the renal failure progression in patients with DKD. This is a pilot randomised, parallel-arm, sham-controlled trial of 60 participants with stable DKD (chronic kidney disease stages 3-4). Participants will be randomly assigned to the intervention or control group undergoing one daily RIP or sham RIP for 3 months, with a subsequent 6-month follow-up period. The primary study outcome is the incidence of end-stage kidney disease. The secondary outcomes include changes in biomarkers of chronic kidney disease progression, cardiovascular outcomes, rates of renal failure requiring dialysis or transplantation, tolerability rates and adverse event incidence. This study has been approved by the Ethics Committee of Xuanwu Hospital of Capital Medical University (no. [2020]154). Our research findings will be published in peer-reviewed journal articles and conference presentations. NCT06654921.