Actively Recruiting
A Phase III Clinical Study on the Efficacy and Safety of HRS-1780 in the Treatment of Patients With Chronic Kidney Disease
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-03-27
1978
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
A Phase III Clinical Study on the Efficacy and Safety of HRS-1780 in the Treatment of Patients With Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to less than 80 years at informed consent
- Estimated glomerular filtration rate (eGFR) between 25 and 90 mL/min/1.73 m2 with urine albumin-to-creatinine ratio (UACR) between 500 and 5000 mg/g, or eGFR between 25 and 60 mL/min/1.73 m2 with UACR between 200 and 500 mg/g
- Serum potassium level of 4.8 mmol/L or lower
- HbA1c less than 10.5%
You will not qualify if you...
- Uncontrolled severe hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) or systolic blood pressure less than 90 mmHg
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal
- Total bilirubin greater than 2 times the upper limit of normal
- Diagnosis or suspicion of polycystic kidney disease or ANCA-associated vasculitis
- Acute kidney injury within 90 days before screening or ongoing dialysis treatment
- Previous or planned kidney transplant during the trial
- Diseases causing hyperkalemia such as Addison's disease
- Significant diseases within 180 days before screening that might interfere with results or increase risk, including respiratory, digestive, cardiovascular, endocrine, immune, urinary, adrenal, blood, nervous, or mental disorders
- Stroke, transient ischemic attack, heart attack, coronary revascularization, or severe heart failure within 90 days before screening, or planned vascular surgery at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Clinical Research Center of Kidney Diseases, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, China, 210002
Actively Recruiting
Research Team
Y
Yi Yue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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