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NCT Number: NCT07419828

A Phase III Clinical Study on the Efficacy and Safety of HRS-1780 in the Treatment of Patients With Chronic Kidney Disease

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Clinical Research Center of Kidney Diseases, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, 210002, China

Location status: Recruiting

Location contact

Zhihong Liu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRS-1780 tablets

Drug

Oral tablets

Placebo

Drug

Oral tablets

Primary outcomes

  1. Time to the first appearance of the composite endpoint:

    Time frame: month 60

    • Progression of kidney disease (initiation of maintenance dialysis or receiving kidney transplantation or continuous eGFR <15 mL/min/1.73m², or death due to kidney disease or a ≥40% decrease in eGFR compared to baseline for at least 4 weeks); or
    • CV Death.

Secondary outcomes

  1. The annualized total slope of eGFR from baseline to 36 months.

    Time frame: month 36

  2. The ratio of UACR to baseline at the 6th month .

    Time frame: month 6

  3. The proportion of participants whose UACR decreased by at least 30% relative to the baseline by the end of treatment.

    Time frame: month 60

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 19, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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