Comparison of the Efficacy and Safety of SGLT2i and GLP-1 Receptor Agonists in Obese Patients With Kidney Disease

March 27, 2024 updated by: RenJi Hospital

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Agree to join this study and sign an informed consent form;
  2. Age ≥ 18 years old and<75 years old;
  3. BMI ≥ 25kg/m ² Or waist circumference ≥ 85cm (male)/≥ 80cm (female) or waist to hip ratio ≥ 0.9 (male)/≥ 0.85 (female);
  4. Confirmed obesity related kidney disease through renal biopsy within six months;
  5. Have received optimized treatment with RAS blockers and/or MRA for at least 3 months;

Exclusion Criteria:

  1. Diagnosed as secondary obesity, such as hypothyroidism, Cushing's syndrome, polycystic ovary syndrome, etc;
  2. Severe renal insufficiency (renal function eGFR<25 ml/min/1.73m2);
  3. 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.
  4. Symptoms of active reproductive and urinary system infections
  5. Severe liver dysfunction (ALT/AST greater than 2.5 times the upper normal limit);
  6. Severe cardiovascular and cerebrovascular diseases, rheumatic and immune diseases;
  7. Serious metabolic diseases, such as diabetes ketoacidosis, hypertonic hyperglycemia, etc;
  8. Late stage malignant tumors;
  9. Have a known history of using drugs that affect glucose and lipid metabolism, such as glucocorticoids, antibiotics, anti anxiety or antidepressants, etc;
  10. Severe bleeding tendency and inability to complete venous blood collection;
  11. There are contraindications for MRI examination, such as patients with pacemakers, nerve stimulators, artificial metal heart valves, etc; Patients with claustrophobia; Epilepsy patients, etc.
  12. Pregnant/lactating women;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Basic treatment
RAS inhibitors（Losartan®️/Valsartan®️） : maintain the maximum dose/maximum tolerated dose.
Drug: RAS inhibitors：Losartan®️/Valsartan®️
Losartan®️/Valsartan®️ : maintain the maximum dose/maximum tolerated dose.
Experimental: Basic treatment+SGLT2i
On the basis of RAS inhibitors treatment, combined with dapagliflozin and titrated to the target dose (10 mg qd).
Drug: RAS inhibitors：Losartan®️/Valsartan®️
Losartan®️/Valsartan®️ : maintain the maximum dose/maximum tolerated dose.
Drug: dapagliflozin：Forxiga®️
Forxiga®️ : titrated to the target dose (10 mg qd).
Experimental: Basic treatment+GLP-1RA
On the basis of RAS inhibitors treatment, combined with semaglutide titrated to the target dose (1 mg qw).
Drug: RAS inhibitors：Losartan®️/Valsartan®️
Losartan®️/Valsartan®️ : maintain the maximum dose/maximum tolerated dose.
Drug: simagliptin：Forxiga®️
Semaglutide®️ : titrated to the target dose (1 mg qw).
Other Names:
  • Semaglutide®️
Experimental: Basic treatment+SGLT2i+GLP-1RA
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®️
Losartan®️/Valsartan®️ : maintain the maximum dose/maximum tolerated dose.
Drug: dapagliflozin：Forxiga®️
Forxiga®️ : titrated to the target dose (10 mg qd).
Drug: simagliptin：Forxiga®️
Semaglutide®️ : titrated to the target dose (1 mg qw).
Other Names:
  • Semaglutide®️

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4、12、24、36、48 WEEK

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decline in glomerular filtration rate
Time Frame: 4、12、24、36、48 WEEK
4、12、24、36、48 WEEK
Changes in BMI
Time Frame: 4、12、24、36、48 WEEK
Body mass index
4、12、24、36、48 WEEK
changes in fasting blood glucose
Time Frame: 4、12、24、36、48 WEEK
4、12、24、36、48 WEEK

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 17, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2023-0253

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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