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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basic treatment | Experimental | RAS inhibitors(Losartan®️/Valsartan®️) : maintain the maximum dose/maximum tolerated dose. |
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| Basic treatment+SGLT2i | Experimental | On the basis of RAS inhibitors treatment, combined with dapagliflozin and titrated to the target dose (10 mg qd). |
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| Basic treatment+GLP-1RA | Experimental | On the basis of RAS inhibitors treatment, combined with semaglutide titrated to the target dose (1 mg qw). |
|
| Basic treatment+SGLT2i+GLP-1RA | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAS inhibitors:Losartan®️/Valsartan®️ | Drug | Losartan®️/Valsartan®️ : maintain the maximum dose/maximum tolerated dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change 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. | 4、12、24、36、48 WEEK |
| Measure | Description | Time Frame |
|---|---|---|
| Decline in glomerular filtration rate | 4、12、24、36、48 WEEK | |
| Changes in BMI | Body mass index | 4、12、24、36、48 WEEK |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Wang | Contact | +8613621964604 | qinwang_1975@126.com | |
| Wei Jin | Contact | +8615026696535 | jinwei_xj@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital Affiliated to Shanghai JIAO TONG University school of medicine | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| dapagliflozin:Forxiga®️ | Drug | Forxiga®️ : titrated to the target dose (10 mg qd). |
|
| simagliptin:Forxiga®️ | Drug | Semaglutide®️ : titrated to the target dose (1 mg qw). |
|
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| changes in fasting blood glucose |
| 4、12、24、36、48 WEEK |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |