ObesityNCT06344247
Comparison of the Efficacy and Safety of SGLT2i and GLP-1 Receptor Agonists in Obese Patients With Kidney Disease
A study testing RAS inhibitors：Losartan®️/Valsartan®️, dapagliflozin：Forxiga®️ and simagliptin：Forxiga®️ in people with Obesity and Chronic Kidney Diseases, run by RenJi Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Chronic Kidney Diseases
- What is being tested?
- RAS inhibitors：Losartan®️/Valsartan®️, dapagliflozin：Forxiga®️ and simagliptin：Forxiga®️
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agree to join this study and sign an informed consent form;
- Age ≥ 18 years old and<75 years old;
- BMI ≥ 25kg/m ² Or waist circumference ≥ 85cm (male)/≥ 80cm (female) or waist to hip ratio ≥ 0.9 (male)/≥ 0.85 (female);
- Confirmed obesity related kidney disease through renal biopsy within six months;
- Have received optimized treatment with RAS blockers and/or MRA for at least 3 months;
Who cannot join
- Diagnosed as secondary obesity, such as hypothyroidism, Cushing's syndrome, polycystic ovary syndrome, etc;
- Severe renal insufficiency (renal function eGFR<25 ml/min/1.73m2);
- 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.
- Symptoms of active reproductive and urinary system infections
- Severe liver dysfunction (ALT/AST greater than 2.5 times the upper normal limit);
- Severe cardiovascular and cerebrovascular diseases, rheumatic and immune diseases;
Show all 12Show fewer
- Serious metabolic diseases, such as diabetes ketoacidosis, hypertonic hyperglycemia, etc;
- Late stage malignant tumors;
- Have a known history of using drugs that affect glucose and lipid metabolism, such as glucocorticoids, antibiotics, anti anxiety or antidepressants, etc;
- Severe bleeding tendency and inability to complete venous blood collection;
- There are contraindications for MRI examination, such as patients with pacemakers, nerve stimulators, artificial metal heart valves, etc; Patients with claustrophobia; Epilepsy patients, etc.
- Pregnant/lactating women;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital Affiliated to Shanghai JIAO TONG University school of medicine
Shanghai, Shanghai Municipality, 200127
wei jin, +8615026696535, jinwei_xj@126.com
About this study
Official title: Comparison of the Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors and Glucagon-like Peptide-1 Receptor Agonists in Obese Patients With Kidney Disease: a Single Center, Prospective, Exploratory Study
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.
Read more
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).
- Conditions
- Obesity, Chronic Kidney Diseases
- Being tested
- RAS inhibitors：Losartan®️/Valsartan®️, dapagliflozin：Forxiga®️, simagliptin：Forxiga®️
- Keywords
- Obesity, Chronic kidney disease, Sodium glucose cotransporter 2 inhibitors (SGLT2i), Glucagon like peptide-1 receptor agonists (GLP-1RA)
- Medical subject headings
- Obesity, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAS inhibitors：Losartan®️/Valsartan®️Drug
Losartan®️/Valsartan®️ : maintain the maximum dose/maximum tolerated dose.
dapagliflozin：Forxiga®️Drug
Forxiga®️ : titrated to the target dose (10 mg qd).
simagliptin：Forxiga®️Drug
Also called Semaglutide®️
Semaglutide®️ : titrated to the target dose (1 mg qw).
| Study group | Role | What they receive |
|---|---|---|
| Basic treatment | Experimental | RAS inhibitors（Losartan®️/Valsartan®️） : maintain the maximum dose/maximum tolerated dose. Receives: Drug: RAS inhibitors：Losartan®️/Valsartan®️ |
| Basic treatment+SGLT2i | Experimental | On the basis of RAS inhibitors treatment, combined with dapagliflozin and titrated to the target dose (10 mg qd). Receives: Drug: RAS inhibitors：Losartan®️/Valsartan®️; Drug: dapagliflozin：Forxiga®️ |
| Basic treatment+GLP-1RA | Experimental | On the basis of RAS inhibitors treatment, combined with semaglutide titrated to the target dose (1 mg qw). Receives: Drug: RAS inhibitors：Losartan®️/Valsartan®️; Drug: simagliptin：Forxiga®️ |
| 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). Receives: Drug: RAS inhibitors：Losartan®️/Valsartan®️; Drug: dapagliflozin：Forxiga®️; Drug: simagliptin：Forxiga®️ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4、12、24、36、48 WEEK
Secondary outcomes (3)
Decline in glomerular filtration rate
Measured: 4、12、24、36、48 WEEK
Changes in BMI
Body mass index
Measured: 4、12、24、36、48 WEEK
changes in fasting blood glucose
Measured: 4、12、24、36、48 WEEK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Sep 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344247
- Sponsor's protocol ID
- IIT-2023-0253
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors and Glucagon-like Peptide-1 Receptor Agonists in Obese Patients With Kidney Disease: a Single Center, Prospective, Exploratory Study
- ClinicalTrials.gov ID
- NCT06344247
- Acronym / sponsor ID
- IIT-2023-0253
- Conditions
- Obesity, Chronic Kidney Diseases
- Keywords
- Obesity, Chronic kidney disease, Sodium glucose cotransporter 2 inhibitors (SGLT2i), Glucagon like peptide-1 receptor agonists (GLP-1RA)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Basic treatment | Experimental | Drug: RAS inhibitors：Losartan®️/Valsartan®️RAS inhibitors（Losartan®️/Valsartan®️） : maintain the maximum dose/maximum tolerated dose. |
| Basic treatment+SGLT2i | Experimental | Drug: RAS inhibitors：Losartan®️/Valsartan®️, Drug: dapagliflozin：Forxiga®️On the basis of RAS inhibitors treatment, combined with dapagliflozin and titrated to the target dose (10 mg qd). |
| Basic treatment+GLP-1RA | Experimental | Drug: RAS inhibitors：Losartan®️/Valsartan®️, Drug: simagliptin：Forxiga®️On the basis of RAS inhibitors treatment, combined with semaglutide titrated to the target dose (1 mg qw). |
| Basic treatment+SGLT2i+GLP-1RA | Experimental | Drug: RAS inhibitors：Losartan®️/Valsartan®️, Drug: dapagliflozin：Forxiga®️, 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Agree to join this study and sign an informed consent form;
- Age ≥ 18 years old and<75 years old;
- BMI ≥ 25kg/m ² Or waist circumference ≥ 85cm (male)/≥ 80cm (female) or waist to hip ratio ≥ 0.9 (male)/≥ 0.85 (female);
- Confirmed obesity related kidney disease through renal biopsy within six months;
- Have received optimized treatment with RAS blockers and/or MRA for at least 3 months;
Key exclusion criteria (12 listed)
- Diagnosed as secondary obesity, such as hypothyroidism, Cushing's syndrome, polycystic ovary syndrome, etc;
- Severe renal insufficiency (renal function eGFR<25 ml/min/1.73m2);
- 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.
- Symptoms of active reproductive and urinary system infections
- Severe liver dysfunction (ALT/AST greater than 2.5 times the upper normal limit);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAS inhibitors：Losartan®️/Valsartan®️Losartan®️/Valsartan®️ : maintain the maximum dose/maximum tolerated dose. | Drug | Basic treatment, Basic treatment+GLP-1RA, Basic treatment+SGLT2i, Basic treatment+SGLT2i+GLP-1RA |
| dapagliflozin：Forxiga®️Forxiga®️ : titrated to the target dose (10 mg qd). | Drug | Basic treatment+SGLT2i, Basic treatment+SGLT2i+GLP-1RA |
| simagliptin：Forxiga®️Also: Semaglutide®️Semaglutide®️ : titrated to the target dose (1 mg qw). | Drug | Basic treatment+GLP-1RA, Basic treatment+SGLT2i+GLP-1RA |
Primary outcome
Change of 24-hour urine protein quantification
Time frame: 4、12、24、36、48 WEEK
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.
3 secondary outcomes
Decline in glomerular filtration rate
Time frame: 4、12、24、36、48 WEEK
Changes in BMI
Time frame: 4、12、24、36、48 WEEK
changes in fasting blood glucose
Time frame: 4、12、24、36、48 WEEK
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAS inhibitors：Losartan®️/Valsartan®️, dapagliflozin：Forxiga®️ and simagliptin：Forxiga®️ in people with Obesity and Chronic Kidney Diseases, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qin Wang (+8613621964604, qinwang_1975@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of 24-hour urine protein quantification (time frame: 4、12、24、36、48 WEEK). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.