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

NCT07116928 | Not Yet Recruiting Phase 4

• 1 other identifier: HDHYJ-LC-2
• Study Type: interventional
• Target: 1,244
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

T2DM (Type 2 Diabetes Mellitus); CKD - Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

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

  Baseline to Week 120

Secondary Outcomes (6)

• Time to the first occurrence of kidney disease progression

  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

  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

  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

  from baseline to week 120

• Changes in the scores of the Kidney Disease Quality of Life-36 Scale (KDQOL-36) compared to the baseline

  from baseline to week 120

Other Outcomes (4)

• time to the first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure

  from baseline to week 120

• Changes in liver stiffness measurement (LSM) of liver transient elastography

  from baseline to week 52 and 120

• change in the staging of diabetic retinopathy measured by non-mydriatic fundus photography

  from baseline to week 52 and 120

Study Arms (2)

ganagliflozin

EXPERIMENTAL

50 mg Once daily, 120 weeks

Drug: ganagliflozin

placebo

PLACEBO COMPARATOR

50 mg Once daily, 120 weeks

Drug: Placebo

Interventions

ganagliflozin DRUG

50 mg Once daily, 120 weeks

ganagliflozin

Placebo DRUG

50 mg Once daily, 120 weeks

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai sixth People's Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaofen Qian

CONTACT

+86-0571-89908582; qianxiaofen@eastchinapharm.com

Wanting Zhang

CONTACT

+86-0571-89905517; zhangwanting@eastchinapharm.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 12, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): October 30, 2031
• Study Completion (Estimated): December 30, 2031
• Last Updated: November 18, 2025

Record last verified: 2025-08

Locations

CN (1)