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Using dapagliflozin to treat chronic kidney disease in Chinese adults

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

Phase 4 Interventional AstraZeneca · NCT06610526

This study is testing if the medication dapagliflozin can help prevent chronic kidney disease from getting worse in Chinese adults.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment700 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsimmunotherapy
Locations35 sites (Beijing and 34 other locations)
Trial IDNCT06610526 on ClinicalTrials.gov

What this trial studies

This interventional, multicentre, Phase IV study aims to evaluate the efficacy and safety of dapagliflozin in preventing the progression of chronic kidney disease (CKD) among Chinese adult patients. It is a single-arm, open-label study where participants will receive dapagliflozin and be monitored for outcomes related to kidney function. The study will include patients with specific criteria related to kidney function and albuminuria levels. The goal is to gather comprehensive data on how well dapagliflozin works in this population.

Who should consider this trial

Good fit: Ideal candidates are Chinese adults aged 18 and older with chronic kidney disease and specific levels of kidney function and albuminuria.

Not a fit: Patients with certain kidney diseases like polycystic kidney disease or those receiving immunosuppressive therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option to slow the progression of chronic kidney disease in Chinese adults.

How similar studies have performed: Previous studies have shown positive outcomes with dapagliflozin in other populations, suggesting potential success in this specific group.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Beijing and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Kidney Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.