Comparing two medications for 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

This study is testing whether two different medications can help obese patients with kidney disease improve their kidney function and reduce protein in their urine.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06344247 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of sodium glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA) in obese patients suffering from kidney disease. Participants will be randomly assigned to one of four groups: optimized treatment, optimized treatment with SGLT2i, optimized treatment with GLP-1RA, or a combination of both. The study will measure changes in 24-hour urinary protein and renal function to determine the effectiveness of these treatments. The trial focuses on patients who have already been on optimized treatment with RAS blockers for at least three months.

Who should consider this trial

Good fit: Ideal candidates are obese adults aged 18 to 75 with confirmed obesity-related kidney disease who have been on optimized treatment with RAS blockers.

Not a fit: Patients with secondary obesity, severe renal insufficiency, or acute kidney injury are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new treatment options that improve kidney function and reduce proteinuria in obese patients with kidney disease.

How similar studies have performed: Other studies have shown promising results with SGLT2i and GLP-1RA in managing obesity and kidney disease, suggesting this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Agree to join this study and sign an informed consent form;
2. Age ≥ 18 years old and\<75 years old;
3. BMI ≥ 25kg/m ² Or waist circumference ≥ 85cm (male)/≥ 80cm (female) or waist to hip ratio ≥ 0.9 (male)/≥ 0.85 (female);
4. Confirmed obesity related kidney disease through renal biopsy within six months;
5. Have received optimized treatment with RAS blockers and/or MRA for at least 3 months;

Exclusion Criteria:

1. Diagnosed as secondary obesity, such as hypothyroidism, Cushing's syndrome, polycystic ovary syndrome, etc;
2. Severe renal insufficiency (renal function eGFR\<25 ml/min/1.73m2);
3. There is acute kidney injury; Defined as: (1) An increase in blood creatinine of ≥ 26.5 within 48 hours μ Mol/L; (2) Within 7 days, the increase in blood creatinine exceeds 1.5 times the baseline value or more; (3) Reduced urine output (\<0.5 ml/kg/h) and lasting for more than 6 hours.
4. Symptoms of active reproductive and urinary system infections
5. Severe liver dysfunction (ALT/AST greater than 2.5 times the upper normal limit);
6. Severe cardiovascular and cerebrovascular diseases, rheumatic and immune diseases;
7. Serious metabolic diseases, such as diabetes ketoacidosis, hypertonic hyperglycemia, etc;
8. Late stage malignant tumors;
9. Have a known history of using drugs that affect glucose and lipid metabolism, such as glucocorticoids, antibiotics, anti anxiety or antidepressants, etc;
10. Severe bleeding tendency and inability to complete venous blood collection;
11. There are contraindications for MRI examination, such as patients with pacemakers, nerve stimulators, artificial metal heart valves, etc; Patients with claustrophobia; Epilepsy patients, etc.
12. Pregnant/lactating women;

Where this trial is running

Shanghai, Shanghai

• Renji Hospital Affiliated to Shanghai JIAO TONG University school of medicine — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Qin Wang

Conditions Obesity; Chronic Kidney Diseases; Chronic kidney disease; Sodium glucose cotransporter 2 inhibitors; Glucagon like peptide-1 receptor agonists