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Dapagliflozin for Chronic Kidney Disease in Chinese Adults

What is being tested

Dapagliflozin

Drug

Who is being recruted

Urogenital Diseases+9

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 130 Years

+22 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: August 2024

See protocol details

Summary

Principal SponsorAstraZeneca

Last updated: January 31, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 23, 2024

Actual date on which the first participant was enrolled.

The study focuses on evaluating the effectiveness and safety of a drug called dapagliflozin for treating chronic kidney disease in Chinese adults. Chronic kidney disease is a long-term condition where the kidneys do not function as well as they should, and this study aims to see if dapagliflozin can help slow down its progression. This research is significant because finding effective treatments can improve quality of life and potentially reduce complications associated with chronic kidney disease. Participants in the study will receive dapagliflozin, which is a medication taken orally. The study observes how the drug affects the progression of chronic kidney disease over time and checks for any side effects to ensure it is safe for use. Being an open-label study, both researchers and participants know what treatment is being given, which helps in assessing the drug's real-world effectiveness and safety in managing the disease.

Official TitleAn 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

NCT06610526

Principal SponsorAstraZeneca

Last updated: January 31, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

731 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 130 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

5 inclusion criteria required to participate

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

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17 exclusion criteria prevent from participating

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

History of organ transplantation

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

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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Dapagliflozin 10 mg once daily

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 34 locations

Suspended

Research Site

Beijing, ChinaOpen Research Site in Google Maps

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Research Site

Beijing, China

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Research Site

Beijing, China

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Research Site

Beijing, China

Suspended34 Study Centers