← Trials/Trial dossier/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
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
1
Recruiting sites
1
Enrollment
48
estimated
Study population
Chronic kidney disease, Obesity / overweight
Key I/E criterion
•BMI ≥25
Primary endpoint
•24-hour urine protein quantification
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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;
Endpoints (4)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointChanges in BMI
Time frame:4、12、24、36、48 WEEK
BMI, change
change from baseline, improvement
Glycemic / diabetes
1 endpointchanges in fasting blood glucose
Time frame:4、12、24、36、48 WEEK
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Renal / kidney
2 endpointsChange of 24-hour urine protein quantification
Time frame:4、12、24、36、48 WEEK
change from baseline, improvement
Decline in glomerular filtration rate
Time frame:4、12、24、36、48 WEEK
eGFR, change
change from baseline, improvement
LOINC 98979-8
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.