Efficacy and Safety of LC-Z300-01 on Proteinuria in Diabetic Patients
- Conditions
- Diabetic Kidney Disease
- Registration Number
- NCT06686758
- Lead Sponsor
- Shanghai Changzheng Hospital
- Brief Summary
The purpose of this RCT is to investigate the efficacy and safety of Sugar cane polysaccharide LC-Z300-01 on proteinuria in participants with diabetic kidney disease (DKD).
- Detailed Description
The incidence of diabetic nephropathy has shown a year-by-year increase, establishing it as the leading cause of uremia. Despite guideline-recommended therapies such as RAS inhibitors, patients with diabetic nephropathy continue to face elevated risks of disease progression, particularly when massive proteinuria persists. Early intervention through nephropathy management can effectively slow renal function deterioration, demonstrating substantial clinical value in mitigating uremia risk.
LC-Z300-01, a sugarcane-derived polysaccharide formulated as a dietary supplement, is being evaluated in this prospective, placebo-controlled, double-blind, randomized clinical trial. Sixty participants with confirmed diabetic nephropathy will be randomly allocated (1:1:1) to receive low-dose polysaccharide, high-dose polysaccharide, or placebo for 24 weeks of intervention and subsequent monitoring.
The predefined primary endpoint is the absolute change in uACR from baseline to week 24. Secondary endpoints encompass: (1) proportion of participants achieving ≥30% reduction in uACR versus baseline; (2) annualized eGFR decline rate; (3) HbA1c trajectory alterations; and (4) time-in-range (TIR) glycemic control metrics. Safety assessments will be conducted for all enrolled subjects receiving ≥1 administered dose.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Rate of change in patient uACR compared to baseline 24 weeks Events based on uACR measure compared to baseline
- Secondary Outcome Measures
Name Time Method Estimated Glomerular Filtration Rate (eGFR) slope 24 weeks Based on eGFR ( by CKD-EPI formula ) slope
Change from baseline in HbA1c 24 weeks Based on instrumental measurements of HbA1c
Change from baseline in glucose time in target range 24 weeks Based on continuous glucose monitoring
The proportion of patients with uACR ≥30% lower than baseline 24 weeks Based on UACR measure compared to baseline
Incidence of adverse reactions Start of treatment until the end of the treatment for 12 weeks The proportion of patients with adverse reactions to the total population
Trial Locations
- Locations (1)
Shanghai Changzheng Hospital
🇨🇳Shanghai, Shanghai, China