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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Sugar cane polysaccharide
placebo
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Rate of change in patient uACR compared to baseline
Events based on uACR measure compared to baseline
Time frame: 24 weeks
Estimated Glomerular Filtration Rate (eGFR) slope
Based on eGFR ( by CKD-EPI formula ) slope
Time frame: 24 weeks
Change from baseline in HbA1c
Based on instrumental measurements of HbA1c
Time frame: 24 weeks
Change from baseline in glucose time in target range
Based on continuous glucose monitoring
Time frame: 24 weeks
The proportion of patients with uACR ≥30% lower than baseline
Based on UACR measure compared to baseline
Time frame: 24 weeks
Incidence of adverse reactions
The proportion of patients with adverse reactions to the total population
Time frame: Start of treatment until the end of the treatment for 12 weeks
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