A Phase III Clinical Study on the Efficacy and Safety of HRS-1780 in the Treatment of Patients With Chronic Kidney Disease
Recruiting · NCT07419828 · Interventional (participants receive a specific treatment) · Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
HRS-1780 tabletsPlacebo
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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≥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%.
Exclusion criteria
- 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
1 location listed.
- National Clinical Research Center of Kidney Diseases, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University - Nanjing, Jiangsu, China