Chronic Kidney Disease
Conditions
Brief summary
The study is a Phase III clinical trial to evaluate the superiority of HRS-1780 tablets compared with placebo in delaying renal function decline in participants with chronic kidney disease (CKD) on the basis of standard treatment.
Interventions
DRUGHRS-1780 tablets
Oral tablets
DRUGPlacebo
Oral tablets
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 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged ≥18 and \<80 years old on the day of signing the informed consent form; * a) The estimated glomerular filtration rate calculated by the CKD-EPI 2009 formula of the Chronic Kidney Disease Epidemiology Collaboration was eGFR≥60 and \<90 mL/min/1.73 m2, and UACR≥300 mg/g; Or b) eGFR≥30 and \<60 mL/min/1.73 m2, and UACR≥30 mg/g ; Or c) eGFR≥25 and \<30 mL/min/1.73 m2； * Serum potassium ≤4.8 mmol/L * HbA1c was less than 10.5%.
Exclusion criteria
* Uncontrolled severe hypertension at the time of screening or randomization (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg); * Alanine aminotransferase (ALT) \>3× upper limit of normal (ULN); Aspartate aminotransferase (AST) \>3×ULN; Total bilirubin \>2.0×ULN; * Diagnosis or suspicion of polycystic kidney disease, anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis; Acute kidney injury occurred within 90 days before screening or hemodialysis or peritoneal dialysis treatment was received; * Have received a kidney transplant in the past or plan to receive a kidney transplant during the trial period; * There are diseases that may cause hyperkalemia during screening or randomization (such as Addison's disease); * Within 180 days prior to the screening, the participants had the following diseases of clinical significance, which, as determined by the investigators, might interfere with the trial results or pose additional risks to the administration of the study drug: including but not limited to respiratory system, digestive system, cardiovascular and cerebrovascular, endocrine, immune, urinary, adrenal, blood, nervous, mental and other diseases; * Stroke, transient ischemic attack, myocardial infarction, coronary revascularization, and decompensated heart failure (NYHA grade III-IV) occurred within 90 days before screening. And/or planned to undergo coronary, carotid or peripheral artery revascularization at the time of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to the first appearance of the composite endpoint: | month 60 | * Progression of kidney disease (initiation of maintenance dialysis or receiving kidney transplantation or continuous eGFR \<15 mL/min/1.73m², or death due to kidney disease or a ≥40% decrease in eGFR compared to baseline for at least 4 weeks); or * CV Death. |
Secondary
| Measure | Time frame |
|---|---|
| The annualized total slope of eGFR from baseline to 36 months. | month 36 |
| The ratio of UACR to baseline at the 6th month . | month 6 |
| The proportion of participants whose UACR decreased by at least 30% relative to the baseline by the end of treatment. | month 60 |
Countries
China
Contacts
CONTACTYi Yue
Outcome results
None listed