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

Sponsor
RenJi Hospital
Study ID
NCT06344247
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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
    Semaglutide®️ : titrated to the target dose (1 mg qw).

Study Details

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).

Key Dates

Start date
Sep 1, 2023
Status verified
Mar 2024
Primary completion
Sep 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Basic treatment
    RAS inhibitors（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).
  • Experimental: Basic treatment+GLP-1RA
    On the basis of RAS inhibitors treatment, combined with semaglutide titrated to the target dose (1 mg qw).
  • 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).

Primary Outcome Measure

Change of 24-hour urine protein quantification [ Time Frame: 4、12、24、36、48 WEEK ]

Central Contacts

Related Studies