NCT06686758

Efficacy and Safety of LC-Z300-01 on Proteinuria in Diabetic Patients

A Trial Investigating the Efficacy and Safety of LC-Z300-01 on Proteinuria in Patients With Diabetic Kidney Disease

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Kidney Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Sugar cane polysaccharide	Sugar cane polysaccharide
DIETARY_SUPPLEMENT	Control	placebo

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-02-01
• Completion: 2026-05-01
• First posted: 2024-11-13
• Last updated: 2025-04-02

Locations

1 site across 1 country: China