Comparison of the Efficacy and Safety of SGLT2i and GLP-1 Receptor Agonists in Obese Patients With Kidney Disease
NCT ID: NCT06344247
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2023-09-01
2025-12-01
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Basic treatment
RAS inhibitors（Losartan®️/Valsartan®️） : maintain the maximum dose/maximum tolerated dose.
RAS inhibitors：Losartan®️/Valsartan®️
Losartan®️/Valsartan®️ : maintain the maximum dose/maximum tolerated dose.
Basic treatment+SGLT2i
On the basis of RAS inhibitors treatment, combined with dapagliflozin and titrated to the target dose (10 mg qd).
RAS inhibitors：Losartan®️/Valsartan®️
Losartan®️/Valsartan®️ : maintain the maximum dose/maximum tolerated dose.
dapagliflozin：Forxiga®️
Forxiga®️ : titrated to the target dose (10 mg qd).
Basic treatment+GLP-1RA
On the basis of RAS inhibitors treatment, combined with semaglutide titrated to the target dose (1 mg qw).
RAS inhibitors：Losartan®️/Valsartan®️
Losartan®️/Valsartan®️ : maintain the maximum dose/maximum tolerated dose.
simagliptin：Forxiga®️
Semaglutide®️ : titrated to the target dose (1 mg qw).
Basic treatment+SGLT2i+GLP-1RA
On the basis of RAS inhibitors treatment, combined with dapagliflozin titrated to the target dose (10 mg qd) and semaglutide titrated to the target dose (1 mg qw).
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).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
75 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Locations
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Renji Hospital Affiliated to Shanghai JIAO TONG University school of medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIT-2023-0253
Identifier Type: -
Identifier Source: org_study_id
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