T2DM (Type 2 Diabetes Mellitus)Phase 4GLOW-CKDNCT07116928
Ganagliflozin on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
A Phase 4 study testing ganagliflozin in people with T2DM (Type 2 Diabetes Mellitus) and CKD - Chronic Kidney Disease, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study aims to investigate the impact of adding Ganagliflozin tablets to the current background therapy on preventing the progression of kidney disease in subjects with type 2 diabetes and chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus), CKD - Chronic Kidney Disease
- What is being tested?
- ganagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,244 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 30 Dec 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female individuals aged 18 years and above;
- Meets the diagnostic criteria for T2DM;
- Meets the diagnostic criteria for CKD, during the screening period（CKD-EPI Formula）: eGFR ≥ 30 to < 60 mL/min/1.73m^2, and UACR is ≥ 30 to < 5000 mg/g; Or eGFR ≥ 60 to < 90 mL/min/1.73m^2, and UACR is ≥ 300 to < 5000 mg/g ;
- HbA1c ≥ 6.5% to ≤ 12%;
- If there are no contraindications or special instructions, all subjects must take a stable dose of ACEi or ARB at least 4 weeks before randomization;
Who cannot join
- Patients with type 1 diabetes or other special types of diabetes;
- A medical history or clinical evidence indicating that the subjects have other primary kidney diseases and secondary kidney diseases other than type 2 diabetes (including but not limited to lupus nephritis, ANCA-related nephritis);
- History of kidney transplantation;
- Blood potassium level > 5.5 mmol/L during the screening period.
- New York Heart Association (NYHA) classification of grade IV during the screening period;
- Experienced ketoacidosis, myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA), hospitalization due to heart failure, or hospitalization due to urinary tract infection or acute kidney injury within 12 weeks before the screening period;
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- Receiving ACEi and ARB in combination;
- Receiving mineralocorticoid receptor antagonists (MRA) or direct renin inhibitors (DRI) within 8 weeks before randomization;
- Receiving drugs with immunosuppressive effects (such as cyclophosphamide, cyclosporine A, tacrolimus, etc.) or biological agents (rituximab, belimumab, etc.) during the 12 weeks before the screening period;
- Receiving SGLT-2 inhibitors or GLP-1 receptor agonists within 8 weeks before the screening, or have previously used SGLT-2 inhibitor drugs and discontinued due to poor efficacy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai sixth People's Hospital
Shanghai, Shanghai Municipality
Weiping Jia, 021-64369181, wpjia@sjtu.edu.cn
Jian Zhou, zhoujian8337@126.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Ganagliflozin on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
This study aims to investigate the impact of adding Ganagliflozin tablets to the current background therapy on preventing the progression of kidney disease in subjects with type 2 diabetes and chronic kidney disease. The efficacy and safety will be evaluated by comparing the effects of Ganagliflozin tablets and placebo tablets added to the current background treatment over 120 weeks
Read the detailed description
A phase IV clinical study on the efficacy and safety of Ganagliflozin in treating patients with type 2 diabetes and chronic kidney disease (multicenter, randomized, double-blind, placebo parallel controlled). 1244 subjects all received a stable dose of ACEi or ARB for at least 4 weeks before enrollment.
Efficacy assessment: Compared with the placebo group, time to the first occurrence of kidney disease progression and the changes in eGFR slope, UACR, and score of KDQOL-36 were evaluated.
- Being tested
- ganagliflozin, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ganagliflozinDrug
50 mg Once daily, 120 weeks
PlaceboDrug
50 mg Once daily, 120 weeks
| Study group | Role | What they receive |
|---|---|---|
| ganagliflozin | Experimental | 50 mg Once daily, 120 weeks Receives: Drug: ganagliflozin |
| placebo | Placebo comparator | 50 mg Once daily, 120 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average change in eGFR as measured by the total slope of eGFR from baseline to week 120
Measured: Baseline to Week 120
Secondary outcomes (6)
Time to the first occurrence of kidney disease progression
The progression of kidney disease is defined as:
- maintenance dialysis or
- receipt of a kidney transplant or
- sustained decline in eGFR to < 15 mL/min/1.73m^2 or
- a sustained decline of ≥ 40% in eGFR from baseline or
- doubling of serum creatinine or
- renal death
Measured: from baseline to Week 120
The proportion of subjects with a total slope of eGFR greater than -3 mL/min/1.73 m²/year from baseline to week 120
Measured: from baseline to week 120
The average change in eGFR as measured by the total slope of eGFR from baseline to week 2 and week 8，from week 2 and week 8 to week 120
Measured: from baseline to week 2 and week 8，from week 2 and week 8 to week 120
The changes in urine albumin-to-creatinine ratio (UACR) at each visit compared to the baseline
Measured: from baseline to week 120
Changes in the scores of the Kidney Disease Quality of Life-36 Scale (KDQOL-36) compared to the baseline
The higher the score, the better the patient's quality of life related to CKD
Measured: from baseline to week 120
Changes in the scores of the European Five-Dimensional Health Scale (EQ-5D-5L) compared to the baseline
Higher the score means the better quality of life
Measured: from baseline to week 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start30 Nov 2025 (estimated)
- Primary completion30 Oct 2031 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- More trials run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,244 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116928
- Sponsor's protocol ID
- HDHYJ-LC-2
- Acronym
- GLOW-CKD
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Ganagliflozin on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07116928
- Acronym / sponsor ID
- GLOW-CKD / HDHYJ-LC-2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,244 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 30 Oct 2031 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 12 Aug 2025 (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.
This study aims to investigate the impact of adding Ganagliflozin tablets to the current background therapy on preventing the progression of kidney disease in subjects with type 2 diabetes and chronic kidney disease. The efficacy and safety will be evaluated by comparing the effects of Ganagliflozin tablets and placebo tablets added to the current background treatment over 120 weeks
Detailed description
A phase IV clinical study on the efficacy and safety of Ganagliflozin in treating patients with type 2 diabetes and chronic kidney disease (multicenter, randomized, double-blind, placebo parallel controlled). 1244 subjects all received a stable dose of ACEi or ARB for at least 4 weeks before enrollment.
Efficacy assessment: Compared with the placebo group, time to the first occurrence of kidney disease progression and the changes in eGFR slope, UACR, and score of KDQOL-36 were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ganagliflozin | Experimental | Drug: ganagliflozin50 mg Once daily, 120 weeks |
| placebo | Placebo comparator | Drug: Placebo50 mg Once daily, 120 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female individuals aged 18 years and above;
- Meets the diagnostic criteria for T2DM;
- Meets the diagnostic criteria for CKD, during the screening period（CKD-EPI Formula）: eGFR ≥ 30 to < 60 mL/min/1.73m^2, and UACR is ≥ 30 to < 5000 mg/g; Or eGFR ≥ 60 to < 90 mL/min/1.73m^2, and UACR is ≥ 300 to < 5000 mg/g ;
- HbA1c ≥ 6.5% to ≤ 12%;
- If there are no contraindications or special instructions, all subjects must take a stable dose of ACEi or ARB at least 4 weeks before randomization;
Key exclusion criteria (10 listed)
- Patients with type 1 diabetes or other special types of diabetes;
- A medical history or clinical evidence indicating that the subjects have other primary kidney diseases and secondary kidney diseases other than type 2 diabetes (including but not limited to lupus nephritis, ANCA-related nephritis);
- History of kidney transplantation;
- Blood potassium level > 5.5 mmol/L during the screening period.
- New York Heart Association (NYHA) classification of grade IV during the screening period;
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 |
|---|---|---|
| ganagliflozin50 mg Once daily, 120 weeks | Drug | ganagliflozin |
| Placebo50 mg Once daily, 120 weeks | Drug | placebo |
Primary outcome
The average change in eGFR as measured by the total slope of eGFR from baseline to week 120
Time frame: Baseline to Week 120
6 secondary outcomes
Time to the first occurrence of kidney disease progression
Time frame: from baseline to Week 120
The proportion of subjects with a total slope of eGFR greater than -3 mL/min/1.73 m²/year from baseline to week 120
Time frame: from baseline to week 120
The average change in eGFR as measured by the total slope of eGFR from baseline to week 2 and week 8，from week 2 and week 8 to week 120
Time frame: from baseline to week 2 and week 8，from week 2 and week 8 to week 120
The changes in urine albumin-to-creatinine ratio (UACR) at each visit compared to the baseline
Time frame: from baseline to week 120
Changes in the scores of the Kidney Disease Quality of Life-36 Scale (KDQOL-36) compared to the baseline
Time frame: from baseline to week 120
Changes in the scores of the European Five-Dimensional Health Scale (EQ-5D-5L) compared to the baseline
Time frame: from baseline to week 120
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 18 Nov 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ganagliflozin in people with T2DM (Type 2 Diabetes Mellitus) and CKD - Chronic Kidney Disease, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site 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 10 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: opening soon, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Contact Xiaofen Qian (+86-0571-89908582, qianxiaofen@eastchinapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The average change in eGFR as measured by the total slope of eGFR from baseline to week 120 (time frame: Baseline to Week 120). 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 18 Nov 2025.