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: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Agree to join this study and sign an informed consent form;

• Age ≥ 18 years old and\<75 years old;

• BMI ≥ 25kg/m ² Or waist circumference ≥ 85cm (male)/≥ 80cm (female) or waist to hip ratio ≥ 0.9 (male)/≥ 0.85 (female);

• Confirmed obesity related kidney disease through renal biopsy within six months;

• Have received optimized treatment with RAS blockers and/or MRA for at least 3 months;

Locations
Other Locations
China
Renji Hospital Affiliated to Shanghai JIAO TONG University school of medicine
RECRUITING
Shanghai
Contact Information
Primary
Qin Wang
qinwang_1975@126.com
+8613621964604
Backup
Wei Jin
jinwei_xj@126.com
+8615026696535
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 48
Treatments
Experimental: Basic treatment
RAS inhibitors(Losartan®️/Valsartan®️) : maintain the maximum dose/maximum tolerated dose.
Experimental: Basic treatment+SGLT2i
On the basis of RAS inhibitors treatment, combined with dapagliflozin and titrated to the target dose (10 mg qd).
Experimental: Basic treatment+GLP-1RA
On the basis of RAS inhibitors treatment, combined with semaglutide titrated to the target dose (1 mg qw).
Experimental: Basic treatment+SGLT2i+GLP-1RA
On the basis of RAS inhibitors treatment, combined with dapagliflozin titrated to the target dose (10 mg qd) and semaglutide titrated to the target dose (1 mg qw).
Related Therapeutic Areas
Sponsors
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov