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

NCT ID: NCT06686758

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2026-05-31

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.

Conditions

Diabetic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sugar cane polysaccharide

Intervention Type: DIETARY_SUPPLEMENT

Sugar cane polysaccharide

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.

Group Type: EXPERIMENTAL

Sugar cane polysaccharide

Intervention Type: DIETARY_SUPPLEMENT

Sugar cane polysaccharide

control

Identical placebo: 2 tablets, 2 times a day , 30 minutes before breakfast and dinner, Oral administration.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DIETARY_SUPPLEMENT

placebo

Interventions

Sugar cane polysaccharide

Sugar cane polysaccharide

Intervention Type: DIETARY_SUPPLEMENT

Control

placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Changzheng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Lin Li, Dr.

Role: CONTACT

lilin_616@163.com

+8613816275180

Other Identifiers

2024SL109

Identifier Type: -

Identifier Source: org_study_id