A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease

Last updated: January 29, 2026
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

4

Condition

Kidney Disease

Focal Segmental Glomerulosclerosis

Nephropathy

Treatment

Dapagliflozin

Clinical Study ID

NCT06610526
D169AC00008
  • Ages 18-130
  • All Genders

Study Summary

The purpose of this study is to describe the efficacy and safety information with dapagliflozin in Chinese patients with chronic kidney disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provision of signed informed consent prior to any study specific procedures

  • Chinese Female or male aged ≥ 18 years at the time of consent

  • eGFR ≥ 25 and ≤ 75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1

  • Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥ 200 and ≤ 5000 mg/g at visit 1

  • Stable, and for the patient maximum tolerated labelled daily dose, treatment withACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated

Exclusion

Exclusion Criteria:

  • Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritisor anti-neutrophil cytoplasmic antibodies-associated vasculitis

  • Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy forprimary or secondary renal disease within 6 months prior to enrolment

  • History of organ transplantation

  • Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment orprevious intolerance of an SGLT2 inhibitor

  • T1DM

  • New York Heart Association class IV Congestive Heart Failure at the time ofenrolment

  • MI, unstable angina, stroke or TIA within 12 weeks prior to enrolment

  • Coronary revascularization (PCI or CABG) or valvular repair/replacement within 12weeks prior to enrolment

  • Any condition outside the renal and CV disease area, such as but not limited tomalignancy, with a life expectancy of less than 2 years based on investigator´sclinical judgement

  • Active malignancy requiring treatment at the time of visit 1 (with the exception ofsuccessfully treated basal cell or treated squamous cell carcinoma)

  • Hepatic impairment (AST or ALT > 3 × ULN; or total bilirubin > 2 × ULN at time ofenrolment). An solated increase in bilirubin in patients with known Gilbert'ssyndrome is not a reason for exclusion

  • Known blood-borne diseases

  • Women of child-bearing potential (ie, those who are not chemically or surgicallysterilised or who are not post-menopausal) who are not willing to use a medicallyaccepted method of contraception that is considered reliable in the judgment of theinvestigator, from the time of signing the informed consent throughout the study and 4 weeks thereafter, OR women who have a positive pregnancy test at enrolment ORwomen who are breast-feeding

  • Involvement in the planning and/or conduct of the study (applies to both AstraZenecapersonnel and/or site personnel)

  • Previous enrolled in the present study

  • Participation in another clinical study with a study intervention during the lastmonth prior to enrolment

  • Inability of the patient, in the opinion of the investigator, to understand and/orcomply with study intervention, procedures and/or follow-up OR any conditions that,in the opinion of the investigator, may render the patient unable to complete thestudy

Study Design

Total Participants: 731
Treatment Group(s): 1
Primary Treatment: Dapagliflozin
Phase: 4
Study Start date:
August 23, 2024
Estimated Completion Date:
May 31, 2027

Study Description

This is an interventional, multicentre, Phase IV, single-arm, open-label study to investigate the efficacy and safety of dapagliflozin to prevent the progression of chronic kidney disease in Chinese adult patients.

Connect with a study center

  • Research Site

    Beijing, 100044
    China

    Site Not Available

  • Research Site

    Beijing 1816670, 100191
    China

    Site Not Available

  • Research Site

    Changchun, 130021
    China

    Site Not Available

  • Research Site

    Changchun 2038180, 130021
    China

    Site Not Available

  • Research Site

    Changsha, 410011
    China

    Site Not Available

  • Research Site

    Changsha 1815577, 410011
    China

    Site Not Available

  • Research Site

    Dongguan, 523059
    China

    Site Not Available

  • Research Site

    Dongguan 1812545, 523059
    China

    Site Not Available

  • Research Site

    Foshan, 528308
    China

    Site Not Available

  • Research Site

    Foshan 1811103, 528308
    China

    Site Not Available

  • Research Site

    Fuyang, 236600
    China

    Site Not Available

  • Research Site

    Fuyang 1810845, 236012
    China

    Site Not Available

  • Research Site

    Fuzhou, 350001
    China

    Site Not Available

  • Research Site

    Fuzhou 1810821, 350001
    China

    Site Not Available

  • Research Site

    Ganzhou, 341099
    China

    Site Not Available

  • Research Site

    Ganzhou 1810638, 341099
    China

    Site Not Available

  • Research Site

    Harbin, 150000
    China

    Site Not Available

  • Research Site

    Harbin 2037013, 150000
    China

    Site Not Available

  • Research Site

    Hefei, 230601
    China

    Site Not Available

  • Research Site

    Hefei 1808722, 230601
    China

    Site Not Available

  • Research Site

    Hengyang, 421001
    China

    Site Not Available

  • Research Site

    Hengyang 1808370, 421001
    China

    Site Not Available

  • Research Site

    Huaian, 223399
    China

    Site Not Available

  • Research Site

    Huizhou, 516001
    China

    Site Not Available

  • Research Site

    Huizhou 1806776, 516001
    China

    Site Not Available

  • Research Site

    Jilin, 132011
    China

    Site Not Available

  • Research Site

    Jilin 2036502, 132011
    China

    Site Not Available

  • Research Site

    Jinan, 250014
    China

    Site Not Available

  • Research Site

    Jinan 1805753, 250014
    China

    Site Not Available

  • Research Site

    Jining, 272029
    China

    Site Not Available

  • Research Site

    Jining 1805518, 272029
    China

    Site Not Available

  • Research Site

    Lanzhou, 730000
    China

    Site Not Available

  • Research Site

    Lanzhou 1804430, 730000
    China

    Site Not Available

  • Research Site

    Linyi, 276199
    China

    Site Not Available

  • Research Site

    Linyi 1803318, 276199
    China

    Site Not Available

  • Research Site

    Nanchang, 330006
    China

    Site Not Available

  • Research Site

    Nanchang 1800163, 330006
    China

    Site Not Available

  • Research Site

    Nanjing, 210029
    China

    Site Not Available

  • Research Site

    Nanjing 1799962, 210029
    China

    Site Not Available

  • Research Site

    Nanning, 530021
    China

    Site Not Available

  • Research Site

    Nanning 1799869, 530021
    China

    Site Not Available

  • Research Site

    Ningbo, 315010
    China

    Site Not Available

  • Research Site

    Ningbo 1799397, 315010
    China

    Site Not Available

  • Research Site

    Shanghai, 200090
    China

    Site Not Available

  • Research Site

    Shanghai 1796236, 200090
    China

    Site Not Available

  • Research Site

    Shenzhen, 518036
    China

    Site Not Available

  • Research Site

    Shenzhen 1795565, 518036
    China

    Site Not Available

  • Research Site

    Suzhou, 215004
    China

    Site Not Available

  • Research Site

    Suzhou 1886760, 215004
    China

    Site Not Available

  • Research Site

    Taian, 271099
    China

    Site Not Available

  • Research Site

    Tianjin, 300121
    China

    Site Not Available

  • Research Site

    Tianjin 1792947, 300121
    China

    Site Not Available

  • Research Site

    Wuhu, 241000
    China

    Site Not Available

  • Research Site

    Wuhu 1791236, 241000
    China

    Site Not Available

  • Research Site

    Wuxi, 214023
    China

    Site Not Available

  • Research Site

    Wuxi 1790923, 214023
    China

    Site Not Available

  • Research Site

    Xi'an 1790630, 710000
    China

    Site Not Available

  • Research Site

    Xiamen, 361004
    China

    Site Not Available

  • Research Site

    Xiamen 1790645, 361004
    China

    Site Not Available

  • Research Site

    Xian, 710000
    China

    Site Not Available

  • Research Site

    Zhumadian, 463000
    China

    Site Not Available

  • Research Site

    Zhumadian 1783873, 463000
    China

    Site Not Available

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