Chronic Kidney DiseasePhase 4NCT06610526
A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease
A Phase 4 study testing Dapagliflozin in people with Chronic Kidney Disease, run by AstraZeneca at 34 sites in China.
Trial summary
The purpose of this study is to describe the efficacy and safety information with dapagliflozin in Chinese patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 731 participants
- Where
- 34 sitesChina
- Study dates
- 23 Aug 2024to 31 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
China34 sites
Research Site
Beijing, 100034
Research Site
Beijing, 100044
Research Site
Beijing, 100068
Research Site
Beijing, 100191
Research Site
Beijing, 102206
Research Site
Changchun, 130021
Research Site
Dongguan, 523059
Research Site
Foshan, 528308
Research Site
Fuyang, 236012
Research Site
Fuzhou, 350001
Research Site
Ganzhou, 341099
Research Site
Harbin, 150000
Research Site
Hefei, 230601
Research Site
Hengyang, 421001
Research Site
Huaian, 223399
Research Site
Huizhou, 516001
Research Site
Jilin City, 132011
Research Site
Jinan, 250014
Research Site
Jining, 272029
Research Site
Lanzhou, 730000
Research Site
Linyi, 276199
Research Site
Nanchang, 330006
Research Site
Nanjing, 210029
Research Site
Nanning, 530021
Research Site
Ningbo, 315010
Research Site
Shanghai, 200090
Research Site
Shenzhen, 518036
Research Site
Suzhou, 215004
Research Site
Taian, 271099
Research Site
Tianjin, 300121
Research Site
Wuhu, 241000
Research Site
Wuxi, 214023
Research Site
Xi'an, 710000
Research Site
Xiamen, 361004
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Dapagliflozin
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Dapagliflozin by oral administration
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin 10 mg once daily Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to a median follow-up time of 24 months
Secondary outcomes (6)
Percentage change in UACR from baseline
Data is reported as descriptive statistics.
Measured: 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.
Measured: 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.
Measured: Up to a median follow-up time of 24 months
Time to death from any cause
Data is reported as descriptive statistics.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start23 Aug 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 731 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610526
- Sponsor's protocol ID
- D169AC00008
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06610526
- Acronym / sponsor ID
- D169AC00008
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 731 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe the efficacy and safety information with dapagliflozin in Chinese patients with chronic kidney disease.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: DapagliflozinDapagliflozin 10 mg once daily |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapagliflozinDapagliflozin by oral administration | Drug | Dapagliflozin |
Primary outcome
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.
Time frame: Up to a median follow-up time of 24 months
Data is reported as descriptive statistics.
6 secondary outcomes
Percentage change in UACR from baseline
Time frame: 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
Time frame: 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
Time frame: Up to a median follow-up time of 24 months
Time to death from any cause
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Chronic Kidney Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin in people with Chronic Kidney Disease, run by AstraZeneca at 34 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Up to a median follow-up time of 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.