Work

Effect of dapagliflozin on renal response in patients with biopsy-confirmed lupus nephritis receiving stable maintenance immunosuppression and renin–angiotensin system inhibition: protocol for the multicentre randomised DAPA-LN trial

Year: 2026

Type: article

Abstract: Introduction Persistent proteinuria despite control of overt disease activity remains an important marker of residual kidney risk in lupus nephritis (LN). Although sodium–glucose cotransporter 2 inhibitors improve kidney outcomes across broader chronic kidney disease populations, randomised evidence specifically in LN remains limited. The DAPA-LN trial will evaluate the efficacy and safety of adjunctive dapagliflozin in patients with biopsy-confirmed LN, clinically stable or low-activity disease and persistent proteinuria.Methods and analysis DAPA-LN is an investigator-initiated, multicentre, randomised, open-label, blinded-endpoint superiority trial conducted at seven hospitals in China. A total of 270 adults with biopsy-confirmed LN (class III or IV with or without class V involvement, or pure class V), persistent proteinuria defined as a urine protein-to-creatinine ratio >0.5 and ≤ 3.5 g/g, and an estimated glomerular filtration rate ≥30 mL/min/1.73 m2 will be randomly assigned in a 1:1 ratio to receive dapagliflozin 10 mg once daily plus standard background therapy or standard background therapy alone. Background therapy will comprise stable maintenance immunosuppression and renin–angiotensin system inhibition with either an ACE inhibitor or an angiotensin receptor blocker as monotherapy. The primary efficacy endpoint will be renal response at week 52, defined by prespecified improvement in proteinuria together with preservation of kidney function. The primary safety endpoint will be the proportion experiencing at least one prespecified clinically significant adverse event of special interest through week 52. Secondary endpoints will assess proteinuria, kidney function, renal flare, immunosuppression intensification, disease activity, hospitalisation and safety outcomes. The primary efficacy analysis will follow the intention-to-treat principle and safety analyses will be descriptive. Exploratory follow-up will continue through week 104.Trial registration number ChiCTR2600131121.

Source: Lupus Science & Medicine

DOI: 10.1136/lupus-2026-002334