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

Shandong Suncadia Medicine

Status and phase: Completed; Phase 2

Conditions: Diabetic Kidney Disease, Type 2 Diabetes

Treatments: Drug: HRS-7535; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06415214

HRS-7535-203

Details and patient eligibility

About

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.

Enrollment: 281 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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281 participants in 3 patient groups, including a placebo group

Group A，Subjects will receive Placebo administered orally

Placebo Comparator group

Treatment:

Drug: Placebo

Group B，Subjects will receive HRS-7535 administered orally

Experimental group

Treatment:

Drug: HRS-7535

Group C，Subjects will receive escalated HRS-7535 administered orally

Experimental group

Treatment:

Drug: HRS-7535