Efficacy and safety of finerenone combined with sodium-glucose cotransporter 2 inhibitors in diabetic kidney disease: protocol for a systematic review and meta-analysis.

Abstract

Diabetic kidney disease (DKD) is the most common complication of diabetes. It is the leading cause of end-stage renal disease and an important risk factor for cardiovascular disease. The mechanism and clinical efficacy of the combination therapy of finerenone and sodium-glucose cotransporter 2 inhibitors (SGLT2i) for DKD have been confirmed, but there is a lack of a comprehensive systematic review of its efficacy and safety. This protocol outlines the methods and procedures for a systematic review and meta-analysis to evaluate the efficacy and safety of the combination therapy of finerenone and SGLT2i for DKD. Eight databases (PubMed, Embase, Cochrane Library, Web of Science, China Science and Technology Journal Database (VIP), China National Knowledge Infrastructure (CNKI), China Biology Medicine disc (CBM) and Wanfang Database) will be searched from the database inception to 31 December 2025. Additional sources like the WHO International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov will also be searched. All randomised controlled clinical trials investigating Finerenone combined with SGLT2i for DKD treatment will be included. Data extraction will encompass study characteristics, participant demographics, intervention protocols, outcome measures and adverse events. Primary outcomes will focus on serum creatinine, estimated glomerular filtration rate and urine albumin-to-creatinine ratio. Cochrane Collaboration's Risk of Bias 2 (RoB 2) tool will be employed to assess methodological quality. Study selection, data extraction and bias evaluation will be conducted independently by two reviewers. Meta-analyses will be performed using statistical software packages including RevMan V.5.4 and STATA V.16.0. Where quantitative synthesis is precluded, descriptive analyses will be undertaken. The Grading of Recommendations, Assessment, Development and Evaluations framework will systematically evaluate the certainty of evidence for all primary and secondary outcomes. This study requires no ethical approval as all data are derived from publicly accessible databases. The research findings will be disseminated through publication in peer-reviewed scientific journals. CRD420251068323.