NCT07116928

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,244 (estimated)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	ganagliflozin	50 mg Once daily, 120 weeks
DRUG	Placebo	50 mg Once daily, 120 weeks

Timeline

• Start date: 2025-11-30
• Primary completion: 2031-10-30
• Completion: 2031-12-30
• First posted: 2025-08-12
• Last updated: 2025-11-18

Locations

1 site across 1 country: China