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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: Placebo; Drug: HRS-1780 tablets

• Study Type: Interventional
• Enrollment (Estimated): 1978
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yi Yue; Phone Number: +0518-82342973; Email: yi.yue@hengrui.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Recruiting
      • National Clinical Research Center of Kidney Diseases, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
      • Principal Investigator: Zhihong Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Oral tablets
Experimental: HRS-1780 tablets	Drug: HRS-1780 tablets; Oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The annualized total slope of the estimated glomerular filtration rate (eGFR) from baseline to 32 months.	month 32

Secondary Outcome Measures

Outcome Measure	Time Frame
The annualized slope of eGFR from 3 months after randomization to the end of treatment.	month 32
The ratio of UACR to the baseline.	month 32
The proportion of participants whose UACR decreased by at least 30% relative to the baseline by the end of treatment.	month 32

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: HRS-1780-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No