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
10 affiliations
- 1Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
- 2Department of Rheumatology and Immunology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
- 3Department of Rheumatology and Immunology, Zhejiang Provincial People’s Hospital, Hangzhou, Zhejiang, China
- 4Department of Rheumatology and Immunology, Panyu Hospital of Chinese Medicine, Guangzhou, China
- 5Department of Nephrology, Liuzhou Workers’ Hospital, Liuzhou, Guangxi, China
- 6Department of Rheumatology and Clinical Immunology, Yueyang Central Hospital, Yueyang, China
- 7Department of Rheumatology and Immunology, The First People’s Hospital of Changde City, Changde, China
- 8Department of Rheumatology and Immunology, The Affiliated Panyu Central Hospital of Guangzhou Medical University, Guangzhou, China
- 9Department of Cardiology, Furong Laboratory, Changsha, Hunan, China
- 10Department of Rheumatology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
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.
Related
- Dapagliflozin Attenuates Post-Infarction Myocardial Fibrosis Associated With the Inhibition of NLRP3-Dependent Inflammation
- Inhibition of Bone Morphogenetic Protein 2 Suppresses the Stemness Maintenance of Cancer Stem Cells in Hepatocellular Carcinoma via the MAPK/ERK Pathway [Retraction].
- c-MET Inhibition Is Accompanied by PD-L1 Upregulation and Immunosuppression-Related Tumor Microenvironment Changes in Esophageal Squamous Cell Carcinoma, With Enhanced Antitumor Activity in Combination With Anti-PD-1 Therapy.
- Individualising Guselkumab Maintenance in Psoriatic Disease: Clinical Profiles Associated with Dosing-Interval Modification in a Multicentre Cohort
- Dapagliflozin vs. Acetazolamide in Patients With Acute Heart Failure: A Randomized Controlled Trial (CHOICE‐AHF)
BibTeX
@article{zhang2026effect,
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}},
author = {Zixi Zhang and Ruyi Tang and Fen Li and Yasong Li and Zhengquan Xie and Xiaoyan Meng and Yan Zeng and Xiang Ren and Haijun Liu and Yixi Li and Pengfei Xu and Wenjing Huang and Linfang Huang and Yao Zou and Ying Xiong and Xia Ouyang and Ni Mao and Jia Wang and Qi Tang and Jiafen Liao and Jin Kang and Xiaofei Peng and Wei Cheng and Shu Li and Yan Ge and Jinfeng Du and Yiming Liu and Bo Peng and Qiming Liu and Xi Xie},
journal = {Lupus Science and Medicine},
year = {2026},
month = oct,
doi = {10.1136/lupus-2026-002334},
url = {https://doi.org/10.1136/lupus-2026-002334},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - 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
AU - Zixi Zhang
AU - Ruyi Tang
AU - Fen Li
AU - Yasong Li
AU - Zhengquan Xie
AU - Xiaoyan Meng
AU - Yan Zeng
AU - Xiang Ren
AU - Haijun Liu
AU - Yixi Li
AU - Pengfei Xu
AU - Wenjing Huang
AU - Linfang Huang
AU - Yao Zou
AU - Ying Xiong
AU - Xia Ouyang
AU - Ni Mao
AU - Jia Wang
AU - Qi Tang
AU - Jiafen Liao
AU - Jin Kang
AU - Xiaofei Peng
AU - Wei Cheng
AU - Shu Li
AU - Yan Ge
AU - Jinfeng Du
AU - Yiming Liu
AU - Bo Peng
AU - Qiming Liu
AU - Xi Xie
PY - 2026
DA - 2026/10/28
JO - Lupus Science and Medicine
DO - 10.1136/lupus-2026-002334
UR - https://doi.org/10.1136/lupus-2026-002334
AB - 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.
SN - 2053-8790
ER -