Clinical trial NCT06344247: Comparison of the Efficacy and Safety of SGLT2i and GLP-1 Receptor Agonists in Obese Patients With Kidney Disease
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Chronic Kidney Diseases
Keywords: Obesity
Chronic kidney disease
Sodium glucose cotransporter 2 inhibitors (SGLT2i)
Glucagon like peptide-1 receptor agonists (GLP-1RA)
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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;

Primary outcomes:
measure: Change of 24-hour urine protein quantification
timeFrame: 4、12、24、36、48 WEEK
Secondary outcomes:
measure: Decline in glomerular filtration rate
timeFrame: 4、12、24、36、48 WEEK
measure: Changes in BMI
timeFrame: 4、12、24、36、48 WEEK
measure: changes in fasting blood glucose
timeFrame: 4、12、24、36、48 WEEK
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai JIAO TONG University school of medicine
state: Shanghai
Study officials:
References: