HRS-1780 to slow kidney function decline in people with chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized Phase III trial comparing HRS-1780 tablets to placebo added to standard-of-care in adults with chronic kidney disease. Eligible participants are adults 18–79 years with specified eGFR and urine albumin-to-creatinine ratio (UACR) ranges and controlled serum potassium and HbA1c levels. Key exclusions include recent acute kidney injury, uncontrolled severe hypertension, marked liver enzyme elevations, polycystic kidney disease, and ANCA-associated vasculitis. The trial is conducted at tertiary centers in Nanjing, Jiangsu, China and uses renal function decline as the primary clinical endpoint.

Why it matters

Who can join: the full rules

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's running

• National Clinical Research Center of Kidney Diseases, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Yi Yue
• Email: yi.yue@hengrui.com
• Phone: +0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.