Lupus & antiphospholipid syndrome

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

Lupus Sci MedPublished investigator-initiated, multicentre, randomised, open-label, blinded-endpoint superiority trial

Study context

Population
Adults with biopsy-confirmed lupus nephritis (LN) (class III or IV with or without class V involvement, or pure class V), persistent proteinuria (urine protein-to-creatinine ratio >0.5 and ≤ 3.5 g/g) and an estimated glomerular filtration rate ≥30 mL/min/1.73 m², at seven hospitals in Chinaplanned total to be randomly assigned
Participants
270 adults
Planned comparison
Dapagliflozin 10 mg once daily plus standard background therapy or standard background therapy alone
Primary endpoint
Renal response, defined by prespecified improvement in proteinuria together with preservation of kidney function
Follow-up
Week 52
Methodological detailsprotocol, 1:1 randomisation, intention-to-treat primary efficacy analysis
  • Protocol
  • 1:1 randomisation
  • Intention-to-treat primary efficacy analysis

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

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. Lupus Sci Med. Published 28 October 2026. doi:10.1136/lupus-2026-002334

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