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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT07419828

Run by

Shandong Suncadia Medicine Co., Ltd.

People needed

5386

Starts

2026-03-13

Expected to finish

2030-05-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%.

You may not qualify if…

• 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

Where it is running

• National Clinical Research Center of Kidney Diseases, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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