| Trial ID: | L0119 |
| Source ID: | NCT06344247
|
| Associated Drug: |
Ras Inhibitors：losartan®️/Valsartan®️
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| Title: |
Comparison of the Efficacy and Safety of SGLT2i and GLP-1 Receptor Agonists in Obese Patients With Kidney Disease
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| Acronym: |
|
| Status: |
RECRUITING
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Obesity|Chronic Kidney Diseases
|
| Interventions: |
DRUG: RAS inhibitors：Losartan®️/Valsartan®️|DRUG: dapagliflozin：Forxiga®️|DRUG: simagliptin：Forxiga®️
|
| Outcome Measures: |
Primary: 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 | Secondary: Decline in glomerular filtration rate, 4、12、24、36、48 WEEK|Changes in BMI, Body mass index, 4、12、24、36、48 WEEK|changes in fasting blood glucose, 4、12、24、36、48 WEEK
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| Sponsor/Collaborators: |
Sponsor: RenJi Hospital
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
|
| Enrollment: |
48
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2023-09-01
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| Completion Date: |
2025-12-01
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| Results First Posted: |
|
| Last Update Posted: |
2024-04-03
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| Locations: |
Renji Hospital Affiliated to Shanghai JIAO TONG University school of medicine, Shanghai, Shanghai, 200127, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06344247
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