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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06344247
• Other study ID #: IIT-2023-0253
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: RenJi Hospital
• Contact: Qin Wang
• Phone: +8613621964604
• Email: qinwang_1975[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Obesity
• Renal Insufficiency, Chronic

Intervention

Drug:
• RAS inhibitors:Losartan®?/Valsartan®?
Losartan®?/Valsartan®? : maintain the maximum dose/maximum tolerated dose.
• dapagliflozin:Forxiga®?
Forxiga®? : titrated to the target dose (10 mg qd).
• simagliptin:Forxiga®?
Semaglutide®? : titrated to the target dose (1 mg qw).

Locations

Country	Name	City	State
China	Renji Hospital Affiliated to Shanghai JIAO TONG University school of medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of 24-hour urine protein quantification	According to KDIGO 2021 glomerular disease management guidelines. ? Remission: proteinuria is reduced, and serum albumin is >30g/L. Renal function is stable. Complete remission (CR): proteinuria is significantly reduced, 24HUTP<0.3g/L, and serum albumin>30g/L. Renal function is stable. Partial response (PR): proteinuria decreases, 24HUTP decreases >50% from baseline and >0.3g/L. Serum albumin>30g/L. Renal function is stable.; ? Invalid: proteinuria is not reduced compared with baseline, and serum albumin is <30g/L. Renal function is stable or declining.; ?Relapse: After achieving CR or PR, proteinuria increases (24-hour urine protein quantification =3.5g/d) and serum albumin decreases, <30g/L. Renal function is stable or declining.	4?12?24?36?48 WEEK
Secondary	Decline in glomerular filtration rate		4?12?24?36?48 WEEK
Secondary	Changes in BMI	Body mass index	4?12?24?36?48 WEEK
Secondary	changes in fasting blood glucose		4?12?24?36?48 WEEK