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Efficacy and Safety of HRS-7535 Tablets in Adults With Diabetic Kidney Disease in Type 2 Diabetes | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HRS-7535 in Adults With Diabetic Kidney Disease in Type 2 Diabetes

NCT06415214•Shandong Suncadia Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

The study is a 16-week multicenter, randomized, double-blind, placebo-controlled, parallel-designed Phase II clinical study. The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with diabetic kidney disease in type 2 diabetes.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;

Locations (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Key Dates

Start Date

June 21, 2024

Primary Completion Date

July 15, 2025

Completion Date

July 25, 2025

Last Updated

January 5, 2026

Enrollment

281

ACTUAL participants

Conditions

Diabetic Kidney Disease, Type 2 Diabetes

Interventions

Placebo

DRUG

HRS-7535

DRUG