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

Launched by SHANGHAI CHANGZHENG HOSPITAL · Nov 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called LC-Z300-01, derived from sugar cane, to see how well it works and how safe it is for people with diabetic kidney disease. The main focus is on reducing a substance called protein in urine, which is an important sign of kidney problems in people with diabetes. The trial is not yet recruiting participants, but it will include adults aged 18 and older who have type 2 diabetes and specific kidney issues confirmed by a healthcare provider.

To be eligible for the trial, participants must have certain health conditions, such as having elevated protein levels in their urine and a stable kidney function. They should also be on specific medications for their diabetes and kidney health. Those who have other serious kidney diseases, recent severe health issues, or certain other medical conditions will not be able to participate. If eligible, participants will be asked to provide written consent and will be closely monitored throughout the study to see how they respond to the treatment.

Gender

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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.