Diabetic Kidney Disease, Type 2 Diabetes
Conditions
Brief 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.
Interventions
DRUGPlacebo
Placebo
DRUGHRS-7535
HRS-7535
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of UACR at week 16 to UACR at baseline | at Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in insulin at Week 16 | at Week 16 |
| Change from baseline in c-peptide at Week 16 | at Week 16 |
| Change from baseline in body weight at Week 16 | at Week 16 |
| Proportion of subjects receiving glycemic rescue medicine at Week 16 | at Week 16 |
| A summary of adverse events, including serious adverse events (SAEs), and hypoglycemic event at Week 16 | at Week 16 |
| Change from baseline in FPG at Week 16 | at Week 16 |
| 24 hour urine analysis results at Week 16 | at Week 16 |
| Proportion of subjects with a 30% decrease in UACR from baseline at Week 16 | at Week 16 |
| Change from baseline in eGFR at Week 16 | at Week 16 |
| Change from baseline in HbA1c at Week 16 | at Week 16 |
| Proportion of subjects reaching the target of HbA1c (<7.0%、<6.5%) at Week 16 | at Week 16 |
Countries
China
Outcome results
None listed