Clinical trial NCT06415214: Efficacy and Safety of HRS-7535 Tablets in Adults With Type 2 Diabetic Kidney Disease
Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HRS-7535 in Adults With Type 2 Diabetic Kidney Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Type 2 Diabetic Kidney Disease
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-16
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 type 2 diabetic kidney disease.


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;

Primary outcomes:
measure: Ratio of UACR at week 16 to UACR at baseline
timeFrame: at Week 16
Secondary outcomes:
measure: 24 hour urine analysis results at Week 16
timeFrame: at Week 16
measure: Proportion of subjects with a 30% decrease in UACR from baseline at Week 16
timeFrame: at Week 16
measure: Change from baseline in eGFR at Week 16
timeFrame: at Week 16
measure: Change from baseline in HbA1c at Week 16
timeFrame: at Week 16
measure: Proportion of subjects reaching the target of HbA1c (<7.0%、<6.5%) at Week 16
timeFrame: at Week 16
measure: Change from baseline in FPG at Week 16
timeFrame: at Week 16
measure: Change from baseline in insulin at Week 16
timeFrame: at Week 16
measure: Change from baseline in c-peptide at Week 16
timeFrame: at Week 16
measure: Change from baseline in body weight at Week 16
timeFrame: at Week 16
measure: Proportion of subjects receiving glycemic rescue medicine at Week 16
timeFrame: at Week 16
measure: A summary of adverse events, including serious adverse events (SAEs), and hypoglycemic event at Week 16
timeFrame: at Week 16
Other outcomes:
Locations:
Study officials:
References: