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

NCT06686758 | Not Yet Recruiting DMC

• 1 other identifier: 2024SL109
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Rate of change in patient uACR compared to baseline

  Events based on uACR measure compared to baseline

  24 weeks

Secondary Outcomes (5)

• Estimated Glomerular Filtration Rate (eGFR) slope

  24 weeks

• Change from baseline in HbA1c

  24 weeks

• Change from baseline in glucose time in target range

  24 weeks

• The proportion of patients with uACR ≥30% lower than baseline

  24 weeks

• Incidence of adverse reactions

  Start of treatment until the end of the treatment for 12 weeks

Study Arms (3)

low-dose LC-Z300-01

EXPERIMENTAL

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

high-dose LC-Z300-01

EXPERIMENTAL

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

control

PLACEBO COMPARATOR

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

Dietary Supplement: Control

Interventions

Sugar cane polysaccharide DIETARY_SUPPLEMENT

Sugar cane polysaccharide

high-dose LC-Z300-01; low-dose LC-Z300-01

Control DIETARY_SUPPLEMENT

placebo

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Clinically diagnosed type 2 diabetes mellitus with biopsy-proven or clinically confirmed diabetic kidney disease.
• HbA1c ≤9% at screening.
• Elevated albuminuria defined as either: uACR ≥30 mg/g on ≥2 occasions within 3 months or sustained proteinuria \>300 mg/24-hour urine collection.
• eGFR ≥60 mL/min/1.73 m² (CKD-EPI equation) at baseline.
• 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).
• 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.
• Capacity to provide written informed consent (self or via legally authorized representative).

You may not qualify if:

• Type 1 diabetes or secondary diabetes.
• Acute metabolic complications within 6 months: diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), severe hypoglycemia requiring hospitalization.
• 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.).
• 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.).
• patients who have received dialysis treatment for acute kidney injury within 6 months or who are expected to undergo dialysis during the study.
• patients with a history of malignancy within 5 years.
• participation in other clinical studies within 3 months.
• Pregnant or lactating women.
• hypersensitivity to any of the components of the interventions in this study.
• alcohol or other drug abuse, and other conditions deemed by the investigator to be inappropriate for participation in this study.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 20003, China

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Lin Li, Dr.

CONTACT

+8613816275180; lilin_616@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start: April 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

CN (1)