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

Launched by SHANDONG SUNCADIA MEDICINE CO., LTD. · May 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called HRS-7535 to see if it is effective and safe for adults with type 2 diabetic kidney disease. The trial will last 16 weeks and involves different medical centers. It aims to find out how well HRS-7535 works compared to a placebo, which is a dummy treatment that doesn’t contain the active drug. To participate, you need to be between 18 and 75 years old, have been diagnosed with diabetic kidney disease, and meet certain health criteria, such as having stable blood sugar levels and a specific range of kidney function.

If you join the trial, you will be randomly assigned to receive either HRS-7535 or a placebo, and neither you nor the researchers will know which one you have until the study is completed. This is to ensure that the results are unbiased. Participants will be monitored closely during the study to check for any side effects and to see how well the medication is working. It's important to note that certain conditions, like recent heart problems or pregnancy, may make someone ineligible to participate. Overall, this trial is an important step in finding new treatments for people with diabetic kidney disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female subjects, 18-75 years of age at the time of signing informed consent;
• • 2. Body weight ≥50 kg, 20.0 kg/m2 ≤BMI ≤40.0 kg/m2;
• • 3. Diabetic kidney disease was diagnosed, and the eGFR≥30 mL/min/1.73 m2;
• • 4. Had a history of T2DM at least 3 months, or had diabetic retinopathy as assessed by the investigators;
• • 5. UACR ≥300 and \<3000 mg/g;
• • 6. HbA1c ≥6.5% and ≤10.0%;
• • 7. 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;
• • 8. Use hypoglycemic drugs for ≥3 months (the dosage of SGLT2i remains stable if used);
• • 9. Able and willing to provide a written informed consent;
• Exclusion Criteria:
• • 1. Have type 1 diabetes mellitus or specific type of diabetes;
• • 2. Acute kidney injury or dialysis treatment within 6 months;
• • 3. Kidney transplantation is planned during the trial;
• • 4. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
• • 5. 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;
• • 6. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
• • 7. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;