A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease
NCT ID: NCT06610526
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
700 participants
INTERVENTIONAL
2024-08-23
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dapagliflozin
Dapagliflozin 10 mg once daily
Dapagliflozin
Dapagliflozin by oral administration
Interventions
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Dapagliflozin
Dapagliflozin by oral administration
Eligibility Criteria
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Inclusion Criteria
* 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 with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated
Exclusion Criteria
* Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary 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 or previous intolerance of an SGLT2 inhibitor
* T1DM
* New York Heart Association class IV Congestive Heart Failure at the time of enrolment
* MI, unstable angina, stroke or TIA within 12 weeks prior to enrolment
* Coronary revascularization (PCI or CABG) or valvular repair/replacement within 12 weeks prior to enrolment
* Any condition outside the renal and CV disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigator´s clinical judgement
* Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma)
* Hepatic impairment (AST or ALT \> 3 × ULN; or total bilirubin \> 2 × ULN at time of enrolment). An solated increase in bilirubin in patients with known Gilbert's syndrome is not a reason for exclusion
* Known blood-borne diseases
* Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator, 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 OR women who are breast-feeding
* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca personnel and/or site personnel)
* Previous enrolled in the present study
* Participation in another clinical study with a study intervention during the last month prior to enrolment
* Inability of the patient, in the opinion of the investigator, to understand and/or comply 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 the study
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Changchun, , China
Research Site
Changsha, , China
Research Site
Dongguan, , China
Research Site
Foshan, , China
Research Site
Fuyang, , China
Research Site
Fuyang, , China
Research Site
Fuzhou, , China
Research Site
Ganzhou, , China
Research Site
Harbin, , China
Research Site
Hefei, , China
Research Site
Hengyang, , China
Research Site
Huaian, , China
Research Site
Huizhou, , China
Research Site
Jilin, , China
Research Site
Jinan, , China
Research Site
Jining, , China
Research Site
Lanzhou, , China
Research Site
Linyi, , China
Research Site
Nanchang, , China
Research Site
Nanjing, , China
Research Site
Nanning, , China
Research Site
Ningbo, , China
Research Site
Shanghai, , China
Research Site
Shenzhen, , China
Research Site
Suzhou, , China
Research Site
Taian, , China
Research Site
Tianjin, , China
Research Site
Wuhu, , China
Research Site
Wuxi, , China
Research Site
Xi'an, , China
Research Site
Xiamen, , China
Research Site
Zhumadian, , China
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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D169AC00008
Identifier Type: -
Identifier Source: org_study_id