Tests a sugar cane supplement for kidney protein leakage in diabetes
Tests a sugar cane supplement in adults with kidney disease caused by diabetes.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of LC-Z300-01 on Proteinuria in Diabetic Patients
Key facts
- Where
- Shanghai, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 2 diabetes and diabetic kidney disease who have protein in the urine and are already on stable kidney-protecting medicine.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Type 2 diabetes with diabetic kidney disease (confirmed by biopsy or clinically). Urine albumin-to-creatinine ratio (uACR) of 30 mg/g or more on at least 2 occasions within 3 months, or more than 300 mg of protein in 24-hour urine. eGFR of 60 mL/min/1.73 m² or more. HbA1c of 9% (75 mmol/mol) or less.
- Earlier treatment
- Stable treatment with an ACE inhibitor or ARB at the highest dose the person tolerates for at least 4 weeks, or documented intolerance confirmed by a nephrologist. If taking SGLT2 inhibitors or non-steroidal mineralocorticoid receptor antagonists, a stable dose for at least 4 weeks or a promise to keep the dose steady during the trial.
Main reasons for not taking part
- Type 1 diabetes or secondary diabetes
- Other kidney diseases or autoimmune diseases that harm the kidneys
- Dialysis for acute kidney injury within 6 months, or dialysis expected during the study
- Cancer within the last 5 years
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Where in China
- Shanghai Changzheng HospitalShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Changzheng Hospital
- Trial code
- NCT06686758
- Record updated
- 2 April 2025
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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).
Exclusion: patients who have received dialysis treatment for acute kidney injury within 6 months or who are expected to undergo dialysis during the study; Type 1 diabetes or secondary diabetes; 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 with a history of malignancy within 5 years; 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; Acute metabolic complications within 6 months: diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), severe hypoglycemia requiring hospitalization; participation in other clinical studies within 3 months; Pregnant or lactating women.