{
  "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.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China",
    "Department of Rheumatology and Immunology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China",
    "Department of Rheumatology and Immunology, Zhejiang Provincial People’s Hospital, Hangzhou, Zhejiang, China",
    "Department of Rheumatology and Immunology, Panyu Hospital of Chinese Medicine, Guangzhou, China",
    "Department of Nephrology, Liuzhou Workers’ Hospital, Liuzhou, Guangxi, China",
    "Department of Rheumatology and Clinical Immunology, Yueyang Central Hospital, Yueyang, China",
    "Department of Rheumatology and Immunology, The First People’s Hospital of Changde City, Changde, China",
    "Department of Rheumatology and Immunology, The Affiliated Panyu Central Hospital of Guangzhou Medical University, Guangzhou, China",
    "Department of Cardiology, Furong Laboratory, Changsha, Hunan, China",
    "Department of Rheumatology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 30,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Zixi Zhang"
    },
    {
      "affs": [
        1
      ],
      "name": "Ruyi Tang"
    },
    {
      "affs": [
        1
      ],
      "name": "Fen Li"
    },
    {
      "affs": [
        2
      ],
      "name": "Yasong Li"
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    {
      "affs": [
        3
      ],
      "name": "Zhengquan Xie"
    },
    {
      "affs": [
        4
      ],
      "name": "Xiaoyan Meng"
    },
    {
      "affs": [
        5
      ],
      "name": "Yan Zeng"
    },
    {
      "affs": [
        6
      ],
      "name": "Xiang Ren"
    },
    {
      "affs": [
        7
      ],
      "name": "Haijun Liu"
    },
    {
      "affs": [
        2
      ],
      "name": "Yixi Li"
    },
    {
      "affs": [
        3
      ],
      "name": "Pengfei Xu"
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    {
      "affs": [
        4
      ],
      "name": "Wenjing Huang"
    },
    {
      "affs": [
        5
      ],
      "name": "Linfang Huang"
    },
    {
      "affs": [
        6
      ],
      "name": "Yao Zou"
    },
    {
      "affs": [
        6
      ],
      "name": "Ying Xiong"
    },
    {
      "affs": [
        7
      ],
      "name": "Xia Ouyang"
    },
    {
      "affs": [
        1
      ],
      "name": "Ni Mao"
    },
    {
      "affs": [
        1
      ],
      "name": "Jia Wang"
    },
    {
      "affs": [
        1
      ],
      "name": "Qi Tang"
    },
    {
      "affs": [
        1
      ],
      "name": "Jiafen Liao"
    },
    {
      "affs": [
        1
      ],
      "name": "Jin Kang"
    },
    {
      "affs": [
        1
      ],
      "name": "Xiaofei Peng"
    },
    {
      "affs": [
        1
      ],
      "name": "Wei Cheng"
    },
    {
      "affs": [
        1
      ],
      "name": "Shu Li"
    },
    {
      "affs": [
        1
      ],
      "name": "Yan Ge"
    },
    {
      "affs": [
        1
      ],
      "name": "Jinfeng Du"
    },
    {
      "affs": [
        1
      ],
      "name": "Yiming Liu"
    },
    {
      "affs": [
        0
      ],
      "name": "Bo Peng"
    },
    {
      "affs": [
        0,
        8
      ],
      "name": "Qiming Liu",
      "orcid": "0000-0003-0282-4313"
    },
    {
      "affs": [
        9
      ],
      "name": "Xi Xie",
      "orcid": "0000-0002-9296-2324"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/26nnaga6qghx4.bib",
  "cited_by": 0,
  "doi": "10.1136/lupus-2026-002334",
  "fulltext_url": "https://lupus.bmj.com/content/13/2/e002334.full",
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  "pmcid": "PMC13723909",
  "pmid": "42951286",
  "published": "2026-10-28",
  "publisher": "BMJ Publishing Group",
  "ris": "https://research.draconitic.com/paper/26nnaga6qghx4.ris",
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  "title": "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",
  "title_text": "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",
  "type": "peer-reviewed",
  "updated_at": "2026-11-05T12:20:38Z",
  "url": "https://research.draconitic.com/paper/26nnaga6qghx4",
  "venue": "Lupus Science and Medicine",
  "versions": []
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