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

A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase III Study Evaluating the Efficacy and Safety of HRS-1780 in Adult Participants With Chronic Kidney Disease

We will test whether daily HRS-1780 tablets can slow kidney function decline compared with placebo in adults with chronic kidney disease who are on standard treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1978 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07419828 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–79 with chronic kidney disease meeting the trial eGFR and UACR criteria, with serum potassium ≤4.8 mmol/L and HbA1c <10.5%, who can attend site visits and are on standard treatment.

Not a fit: Patients with polycystic kidney disease, ANCA-associated vasculitis, recent acute kidney injury, uncontrolled severe hypertension, or significant liver enzyme elevations are unlikely to be eligible or to benefit from this trial.

Why it matters

Potential benefit: If successful, HRS-1780 could slow progression of kidney disease and delay the need for dialysis or kidney replacement.

How similar studies have performed: The protocol advances to Phase III, implying prior phases showed enough promise to proceed, but this specific compound and indication remain relatively novel in large confirmatory testing.

Eligibility criteria

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≥25 and \<90 mL/min/1.73 m2, and UACR≥500 mg/g and ≤5000 mg/g; Or b) eGFR≥25 and \<60 mL/min/1.73 m2, and UACR≥200 mg/g and \<500 mg/g;
* 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 ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), or systolic blood pressure \<90 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 this trial is running

Nanjing, Jiangsu

• 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

Conditions Chronic Kidney Disease