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

Launched by HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. · Aug 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a medicine called Ganagliflozin to the usual treatment can help slow down kidney damage in people who have type 2 diabetes and chronic kidney disease. The study will compare the effects of Ganagliflozin with a placebo (a pill that doesn’t contain the medicine) over about two and a half years to see if it’s safe and effective in protecting the kidneys.

Adults aged 18 and older with type 2 diabetes and certain levels of kidney function may be eligible to join. Participants need to have stable treatment for their blood pressure and kidney health before starting the study. People with other types of diabetes, serious heart problems, or recent severe health issues won’t be able to participate. If you join, you can expect to take either Ganagliflozin or a placebo along with your current medications and have regular check-ups to monitor your kidney health and overall safety throughout the study. This research could help improve care for people managing both diabetes and kidney disease.

Gender

ALL

Eligibility criteria

• 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 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.