Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase III Study Evaluating the Efficacy and Safety of HRS-1780 in Adults With Chronic Kidney Disease
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-03-27
1978
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating HRS-1780 tablets in a Phase III clinical trial to determine if they work better than a placebo in slowing kidney function decline in adults with chronic kidney disease (CKD) who are receiving standard treatment. This study is sponsored by Shandong Suncadia Medicine Co., Ltd. and aims to assess the safety and effectiveness of HRS-1780 in this population. Participants will be randomly assigned to receive either HRS-1780 tablets or a placebo as oral tablets. The study is double-blind, meaning neither participants nor researchers know who receives the active study drug or placebo. The treatment period lasts up to 32 months, during which kidney function and other health markers will be monitored closely. Throughout the trial, participants will have regular assessments of kidney function using estimated glomerular filtration rate (eGFR) measurements, urine albumin-to-creatinine ratio (UACR), and blood tests such as HbA1c and serum potassium. The main outcome measured is the yearly change in kidney function over 32 months. Safety will be monitored, and participants' health status will be followed during this period, which may last several years.
CONDITIONS
Brief 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 and under 80 years old on the day of signing the informed consent form
- Estimated glomerular filtration rate (eGFR) between 25 and 90 mL/min/1.73 m2 with urine albumin-to-creatinine ratio (UACR) between 50 and 5000 mg/g; or eGFR between 25 and 60 mL/min/1.73 m2 with UACR between 20 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 at screening or randomization (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), or systolic blood pressure below 90 mmHg
- Alanine aminotransferase (ALT) greater than 3 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) greater than 3 times ULN; Total bilirubin greater than 2 times ULN
- Diagnosis or suspicion of polycystic kidney disease or anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis
- Acute kidney injury within 90 days before screening or receiving hemodialysis or peritoneal dialysis treatment
- Previous kidney transplant or planned kidney transplant during the trial
- Diseases causing hyperkalemia during screening or randomization (such as Addison's disease)
- Significant diseases within 180 days prior to screening affecting respiratory, digestive, cardiovascular, cerebrovascular, endocrine, immune, urinary, adrenal, blood, nervous, mental, or other systems
- Stroke, transient ischemic attack, myocardial infarction, coronary revascularization, or decompensated heart failure (NYHA grade III-IV) within 90 days before screening, or planned arterial revascularization at screening time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 32 months
Participants receive oral tablets of either HRS-1780 or a placebo as part of the study to assess the efficacy and safety of the medication for chronic kidney disease.
Regular visits throughout treatment as scheduled by the study team
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
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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