RecruitingNot ApplicableNCT06344247

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


Sponsor

RenJi Hospital

Enrollment

48 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two types of diabetes/weight medications — SGLT2 inhibitors (like empagliflozin or dapagliflozin) and GLP-1 receptor agonists (like semaglutide) — to see which works better for protecting the kidneys in people who are overweight and have obesity-related kidney damage. **You may be eligible if...** - You are between 18 and 74 years old - You are overweight or obese (based on BMI or waist measurements) - You have been diagnosed with obesity-related kidney disease confirmed by a kidney biopsy in the past 6 months - You have been on standard kidney-protective medications (RAS blockers or MRA) for at least 3 months **You may NOT be eligible if...** - Your obesity is caused by a hormonal condition (like hypothyroidism or Cushing's syndrome) - Your kidney function is severely reduced (eGFR below 25) - You are experiencing an acute kidney injury - You have severe liver disease, serious heart or brain conditions, or active urinary/reproductive infections - You have a pacemaker, metal implants, or claustrophobia (due to MRI scans required) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRAS inhibitors:Losartan®️/Valsartan®️

Losartan®️/Valsartan®️ : maintain the maximum dose/maximum tolerated dose.

DRUGdapagliflozin:Forxiga®️

Forxiga®️ : titrated to the target dose (10 mg qd).

DRUGsimagliptin:Forxiga®️

Semaglutide®️ : titrated to the target dose (1 mg qw).


Locations(1)

Renji Hospital Affiliated to Shanghai JIAO TONG University school of medicine

Shanghai, Shanghai Municipality, China

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NCT06344247


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