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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Kidney Disease
• Intervention / Treatment: Dietary supplement: Sugar cane polysaccharide; Dietary supplement: Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lin Li, Dr.; Phone Number: +8613816275180; Email: lilin_616@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 20003
      • Shanghai Changzheng Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Age ≥18 years.
2. Clinically diagnosed type 2 diabetes mellitus with biopsy-proven or clinically confirmed diabetic kidney disease.
3. HbA1c ≤9% at screening.
4. Elevated albuminuria defined as either: uACR ≥30 mg/g on ≥2 occasions within 3 months or sustained proteinuria >300 mg/24-hour urine collection.
5. eGFR ≥60 mL/min/1.73 m² (CKD-EPI equation) at baseline.
6. Stable RAS blockade therapy meeting either: Maximum tolerated dose of ACE inhibitor/ARB for ≥4 weeks pre-screening or documented intolerance to ACEi/ARB (with nephrologist confirmation).
7. If using SGLT2 inhibitors and/or nonsteroidal mineralocorticoid receptor antagonists (ns-MRAs): stable regimen ≥4 weeks pre-enrollment or commitment to maintain dosing throughout study.
8. Capacity to provide written informed consent (self or via legally authorized representative).

Exclusion Criteria

1. Type 1 diabetes or secondary diabetes.
2. Acute metabolic complications within 6 months: diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), severe hypoglycemia requiring hospitalization.
3. Various primary glomerular diseases, other secondary renal diseases (e.g. lupus nephritis, vasculitis renal damage, gouty nephropathy, obstructive nephropathy, chronic pyelonephritis, tumour-associated renal disease, polycystic kidney disease, etc.).
4. Patients with a history of autoimmune diseases that cause renal impairment (including but not limited to systemic lupus erythematosus, systemic small vessel vasculitis, rheumatoid arthritis, ankylosing spondylitis, dry syndrome, etc.).
5. patients who have received dialysis treatment for acute kidney injury within 6 months or who are expected to undergo dialysis during the study.
6. patients with a history of malignancy within 5 years.
7. participation in other clinical studies within 3 months.
8. Pregnant or lactating women.
9. hypersensitivity to any of the components of the interventions in this study.
10. alcohol or other drug abuse, and other conditions deemed by the investigator to be inappropriate for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low-dose LC-Z300-01; Sugar cane polysaccharide LC-Z300-01: 0.5g at a time, 2 times a day , 30 minutes before breakfast and dinner, Oral administration.	Dietary supplement: Sugar cane polysaccharide; Sugar cane polysaccharide
Experimental: high-dose LC-Z300-01; Sugar cane polysaccharide LC-Z300-01: 1.0g at a time, 2 times a day , 30 minutes before breakfast and dinner, Oral administration.	Dietary supplement: Sugar cane polysaccharide; Sugar cane polysaccharide
Placebo Comparator: control; Identical placebo: 2 tablets, 2 times a day , 30 minutes before breakfast and dinner, Oral administration.	Dietary supplement: Control; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of change in patient uACR compared to baseline	Events based on uACR measure compared to baseline	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse reactions	The proportion of patients with adverse reactions to the total population	Start of treatment until the end of the treatment for 12 weeks
Estimated Glomerular Filtration Rate (eGFR) slope	Based on eGFR ( by CKD-EPI formula ) slope	24 weeks
Change from baseline in HbA1c	Based on instrumental measurements of HbA1c	24 weeks
Change from baseline in glucose time in target range	Based on continuous glucose monitoring	24 weeks
The proportion of patients with uACR ≥30% lower than baseline	Based on UACR measure compared to baseline	24 weeks

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urological Manifestations; Diabetes Mellitus; Diabetes Complications; Kidney Diseases; Diabetic Nephropathies; Proteinuria
• Other Study ID Numbers: 2024SL109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No