An interventional study of RAS inhibitors：Losartan®️/Valsartan®️ and dapagliflozin：Forxiga®️ in Obesity and Chronic Kidney Diseases, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment
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).
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's planned enrollment of 48 is below the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →RenJi Hospital is the lead sponsor of 550 studies on the registry; 248 are open to participants now.
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Exclusion Criteria:
RAS inhibitors（Losartan®️/Valsartan®️） : maintain the maximum dose/maximum tolerated dose.
Drug: RAS inhibitors：Losartan®️/Valsartan®️
On the basis of RAS inhibitors treatment, combined with dapagliflozin and titrated to the target dose (10 mg qd).
Drug: RAS inhibitors：Losartan®️/Valsartan®️ · Drug: dapagliflozin：Forxiga®️
On the basis of RAS inhibitors treatment, combined with semaglutide titrated to the target dose (1 mg qw).
Drug: RAS inhibitors：Losartan®️/Valsartan®️ · Drug: simagliptin：Forxiga®️
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).
Drug: RAS inhibitors：Losartan®️/Valsartan®️ · Drug: dapagliflozin：Forxiga®️ · Drug: simagliptin：Forxiga®️
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).
Also known as: Semaglutide®️
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.
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
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Sep 2025, 24 months after the start.
Of 2,253 non-industry interventional studies with no phase under Obesity, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's planned 24 months is close to that.
Counting every sponsor, half of 2,351 studies reached it within 26 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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