A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease
An Interventional, Multicentre, Phase IV, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease
1 other identifier
interventional
731
1 country
34
Brief Summary
The purpose of this study is to describe the efficacy and safety information with dapagliflozin in Chinese patients with chronic kidney disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2024
Typical duration for phase_4
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2024
CompletedStudy Start
First participant enrolled
August 23, 2024
CompletedFirst Posted
Study publicly available on registry
September 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
January 30, 2026
January 1, 2026
2.8 years
August 20, 2024
January 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to the first occurrence of any of the components of the composite: 50% sustained decline in eGFR or Reaching ESRD or CV Death or Renal Death.
Data is reported as descriptive statistics.
Up to a median follow-up time of 24 months
Secondary Outcomes (6)
Percentage change in UACR from baseline
Up to a median follow-up time of 24 months
Time to the first occurrence of any of the components of the composite: ≥ 50% sustained decline in eGFR or Reaching ESRD or Renal death
Up to a median follow-up time of 24 months
Time to the first occurrence of either of the components of the composite: CV death or Hospitalization for heart failure
Up to a median follow-up time of 24 months
Time to death from any cause
Up to a median follow-up time of 24 months
Measure the change in eGFR over time from baseline to the end of treatment and from first on treatment measurement to end of treatment
Up to a median follow-up time of 24 months
- +1 more secondary outcomes
Study Arms (1)
Dapagliflozin
EXPERIMENTALDapagliflozin 10 mg once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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 with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated
You may not qualify if:
- Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or anti-neutrophil cytoplasmic antibodies-associated vasculitis
- 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)
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (34)
Research Site
Beijing, 100034, China
Research Site
Beijing, 100044, China
Research Site
Beijing, 100068, China
Research Site
Beijing, 100191, China
Research Site
Beijing, 102206, China
Research Site
Changchun, 130021, China
Research Site
Dongguan, 523059, China
Research Site
Foshan, 528308, China
Research Site
Fuyang, 236012, China
Research Site
Fuzhou, 350001, China
Research Site
Ganzhou, 341099, China
Research Site
Harbin, 150000, China
Research Site
Hefei, 230601, China
Research Site
Hengyang, 421001, China
Research Site
Huaian, 223399, China
Research Site
Huizhou, 516001, China
Research Site
Jilin, 132011, China
Research Site
Jinan, 250014, China
Research Site
Jining, 272029, China
Research Site
Lanzhou, 730000, China
Research Site
Linyi, 276199, China
Research Site
Nanchang, 330006, China
Research Site
Nanjing, 210029, China
Research Site
Nanning, 530021, China
Research Site
Ningbo, 315010, China
Research Site
Shanghai, 200090, China
Research Site
Shenzhen, 518036, China
Research Site
Suzhou, 215004, China
Research Site
Taian, 271099, China
Research Site
Tianjin, 300121, China
Research Site
Wuhu, 241000, China
Research Site
Wuxi, 214023, China
Research Site
Xi'an, 710000, China
Research Site
Xiamen, 361004, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2024
First Posted
September 24, 2024
Study Start
August 23, 2024
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
January 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.