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

NCT07419828 | Recruiting Phase 3

• 1 other identifier: HRS-1780-301
• Study Type: interventional
• Target: 1,978
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• The annualized total slope of the estimated glomerular filtration rate (eGFR) from baseline to 32 months.

  month 32

Secondary Outcomes (3)

• 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

Study Arms (2)

HRS-1780 tablets

EXPERIMENTAL

Drug: HRS-1780 tablets

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HRS-1780 tablets DRUG

Oral tablets

HRS-1780 tablets

Placebo DRUG

Oral tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210002, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yi Yue

CONTACT

+0518-82342973; yi.yue@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: March 13, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: March 27, 2026

Record last verified: 2025-11

Locations

CN (1)