Efficacy and Safety of HRS-7535 Tablets in Adults With Diabetic Kidney Disease in Type 2 Diabetes

Prior treatment

• Kidney transplantation is planned during the trial;
• History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
• history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;

Other illness

• Have type 1 diabetes mellitus or specific type of diabetes;
• Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;

Other

• Acute kidney injury or dialysis treatment within 6 months;
• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;

• Male or female subjects, 18-75 years of age at the time of signing informed consent;
• Body weight ≥50 kg, 20.0 kg/m2 ≤BMI ≤40.0 kg/m2;
• Diabetic kidney disease was diagnosed, and the eGFR≥30 mL/min/1.73 m2;
• Had a history of T2DM at least 3 months, or had diabetic retinopathy as assessed by the investigators;
• UACR ≥300 and \<3000 mg/g;
• HbA1c ≥6.5% and ≤10.0%;
• ACEI/ARB was used for ≥3 months and ACEI/ARB was stabilized at either the maximum recommended dose (reference to the drug label) or the maximum tolerated dose within 4 weeks;
• Use hypoglycemic drugs for ≥3 months (the dosage of SGLT2i remains stable if used);
• Able and willing to provide a written informed consent;