GLOW-CKDGanagliflozin for Kidney Disease Progression in Type 2 Diabetes
ganagliflozin
+ Placebo
Urogenital Diseases+15
+ Chronic Disease
+ Diabetes Mellitus
Treatment Study
Summary
Study start date: November 30, 2025
Actual date on which the first participant was enrolled.This clinical study aims to investigate the effects of a drug called Ganagliflozin on people who have type 2 diabetes and chronic kidney disease. The study includes 1244 participants who are already receiving treatment with medications known as ACE inhibitors or ARBs for at least four weeks before they join the study. The main goal is to see if Ganagliflozin can help slow down the progression of kidney disease in these individuals, which is important because managing kidney health is a significant concern for those with diabetes. Participants in the study are randomly assigned to receive either Ganagliflozin or a placebo, which is a substance that looks like the drug but has no active ingredients. The study is double-blind, meaning neither the participants nor the researchers know who receives the actual drug. This helps ensure that the results are unbiased. The researchers will monitor the time it takes for kidney disease to worsen and will also look at changes in kidney function, protein levels in urine, and quality of life scores related to kidney health. These measures will help determine the effectiveness and safety of Ganagliflozin for improving kidney health in people with diabetes.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1244 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location