A Phase III Clinical Study on the Efficacy and Safety of HRS-1780 in the Treatment of Patients With Chronic Kidney Disease

Shandong Suncadia Medicine

Status and phase

Enrolling

Phase 3

Conditions

Chronic Kidney Disease

Treatments

Drug: Placebo

Drug: HRS-1780 tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT07419828

HRS-1780-301

Details and patient eligibility

About

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.

Enrollment

1,978 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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