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≥25 and \<90 mL/min/1.73 m2, and UACR≥500 mg/g and ≤5000 mg/g; Or b) eGFR≥25 and \<60 mL/min/1.73 m2, and UACR≥200 mg/g and \<500 mg/g; * 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 ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), or systolic blood pressure \<90 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 |
|---|---|
| The annualized total slope of the estimated glomerular filtration rate (eGFR) from baseline to 32 months. | month 32 |
Secondary
| Measure | Time frame |
|---|---|
| The annualized slope of eGFR from 3 months after randomization to the end of treatment. | month 32 |
| The ratio of UACR to the baseline. | month 32 |
| The proportion of participants whose UACR decreased by at least 30% relative to the baseline by the end of treatment. | month 32 |
Countries
China
Contacts
CONTACTYi Yue
Outcome results
None listed