NCT06344247

Comparison of the Efficacy and Safety of SGLT2i and GLP-1 Receptor Agonists in Obese Patients With Kidney Disease

Comparison of the Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors and Glucagon-like Peptide-1 Receptor Agonists in Obese Patients With Kidney Disease: a Single Center, Prospective, Exploratory Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to exploring the changes in 24-hour urinary protein and renal function in obese patients with kidney disease after the application of sodium glucose cotransporter 2 inhibitors (SGLT2i) and glucagon like peptide-1 receptor agonists (GLP-1RA). Eligible patients were randomly and non-blindly allocated to four groups in a 1:1:1:1 ratio.The first group is the optimized treatment group, and patients in this group maintain the maximum dose/maximum tolerated dose of RAS blocker therapy. The second group is the optimized treatment + SGLT2i group. Participants in this group are titrated to the target dose (10 mg qd) in combination with dapagliflozin on the basis of optimized treatment. The third group is the optimized treatment + GLP-1RA group. Participants in this group will be titrated to the target dose (1mg qw) in combination with semaglutide on the basis of optimized treatment. The last group is the optimized treatment + SGLT2i + GLP-1RA treatment group, that is, based on the optimized treatment, combined with dapagliflozin titrated to the target dose (10 mg qd) and semaglutide titrated to the target dose (1 mg qw).

Conditions

• Obesity
• Chronic Kidney Diseases

Interventions

Type	Name	Description
DRUG	RAS inhibitors：Losartan®️/Valsartan®️	Losartan®️/Valsartan®️ : maintain the maximum dose/maximum tolerated dose.
DRUG	dapagliflozin：Forxiga®️	Forxiga®️ : titrated to the target dose (10 mg qd).
DRUG	simagliptin：Forxiga®️	Semaglutide®️ : titrated to the target dose (1 mg qw).

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2024-04-03
• Last updated: 2024-04-03

Locations

1 site across 1 country: China