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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: Dapagliflozin

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 731
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Research Site
  • Beijing, China, 100044
    • Research Site
  • Beijing, China, 100191
    • Research Site
  • Beijing, China, 102206
    • Research Site
  • Beijing, China, 100068
    • Research Site
  • Changchun, China, 130021
    • Research Site
  • Dongguan, China, 523059
    • Research Site
  • Foshan, China, 528308
    • Research Site
  • Fuyang, China, 236012
    • Research Site
  • Fuzhou, China, 350001
    • Research Site
  • Ganzhou, China, 341099
    • Research Site
  • Harbin, China, 150000
    • Research Site
  • Hefei, China, 230601
    • Research Site
  • Hengyang, China, 421001
    • Research Site
  • Huaian, China, 223399
    • Research Site
  • Huizhou, China, 516001
    • Research Site
  • Jilin, China, 132011
    • Research Site
  • Jinan, China, 250014
    • Research Site
  • Jining, China, 272029
    • Research Site
  • Lanzhou, China, 730000
    • Research Site
  • Linyi, China, 276199
    • Research Site
  • Nanchang, China, 330006
    • Research Site
  • Nanjing, China, 210029
    • Research Site
  • Nanning, China, 530021
    • Research Site
  • Ningbo, China, 315010
    • Research Site
  • Shanghai, China, 200090
    • Research Site
  • Shenzhen, China, 518036
    • Research Site
  • Suzhou, China, 215004
    • Research Site
  • Taian, China, 271099
    • Research Site
  • Tianjin, China, 300121
    • Research Site
  • Wuhu, China, 241000
    • Research Site
  • Wuxi, China, 214023
    • Research Site
  • Xi'an, China, 710000
    • Research Site
  • Xiamen, China, 361004
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated

Exclusion Criteria:

• 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)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dapagliflozin; Dapagliflozin 10 mg once daily	Drug: Dapagliflozin; Dapagliflozin by oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in UACR from baseline	Data is reported as descriptive statistics.	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	Data is reported as descriptive statistics.	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	Data is reported as descriptive statistics.	Up to a median follow-up time of 24 months
Time to death from any cause	Data is reported as descriptive statistics.	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	Data is reported as descriptive statistics.	Up to a median follow-up time of 24 months
To describe the safety profile in Chinese adult patients with CKD treated with dapagliflozin: SAE, DAEs, and clinical chemistry/haematology parameters	The number and percent of subjects with SAE and DAE, and the total number of SAE and DAEs will be provided.; The result and the change from baseline of each clinical chemistry/haematology tests will be summarized at each scheduled visit using summary statistics based on the FAS.	From the administration of study intervention throughout the study until and including the patient's last visit, up to a median follow-up time of 24 months

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; dapagliflozin
• Other Study ID Numbers: D169AC00008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No