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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Losartan®️/Valsartan®️ : maintain the maximum dose/maximum tolerated dose.
Forxiga®️ : titrated to the target dose (10 mg qd).
Semaglutide®️ : titrated to the target dose (1 mg qw).
Renji Hospital Affiliated to Shanghai JIAO TONG University school of medicine
Shanghai, Shanghai Municipality, China
RECRUITINGChange of 24-hour urine protein quantification
According to KDIGO 2021 glomerular disease management guidelines. ① 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. ② Invalid: proteinuria is not reduced compared with baseline, and serum albumin is \<30g/L. Renal function is stable or declining. ③Relapse: 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.
Time frame: 4、12、24、36、48 WEEK
Decline in glomerular filtration rate
Time frame: 4、12、24、36、48 WEEK
Changes in BMI
Body mass index
Time frame: 4、12、24、36、48 WEEK
changes in fasting blood glucose
Time frame: 4、12、24、36、48 WEEK
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