Not Yet RecruitingPhase 4

Ganagliflozin on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

China1,244 participantsStarted 2025-11-30

Plain-language 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. 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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; Exclusion Criteria: * 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; * Receiving ACEi and ARB in combination; * Receiving mineralocorticoid receptor antagonists (MRA) or direct renin inhibitors (DRI) within 8 weeks before randomization; * Receiving …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The average change in eGFR as measured by the total slope of eGFR from baseline to week 120

Timeframe: Baseline to Week 120

Trial details

NCT IDNCT07116928

SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2031-10-30

Contact for this trial

Xiaofen Qian

+86-0571-89908582 qianxiaofen@eastchinapharm.com

View on ClinicalTrials.gov More T2DM (Type 2 Diabetes Mellitus) trials