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

Prior treatment

• patients who have received dialysis treatment for acute kidney injury within 6 months or who are expected to undergo dialysis during the study.

Other illness

• 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.

Other

• 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.

• 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).