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

NCT07419828
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
5,386
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Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
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Start date
2026-03-13
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Number of sites
1
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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.
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Short title
A Phase III Clinical Study on the Efficacy and Safety of HRS-1780 in the Treatment of Patients With Chronic Kidney Disease
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Official 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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2030-05-01
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First posted
2026-02-19
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Registry last updated
2026-07-17
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Primary completion date
2030-04-01
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Start date
2026-03-13
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Participants
5,386
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Participant count basis
Estimated
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Planned participants
5,386
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Protocol amendments
1
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Number of sites
1
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Registry sponsor category
Industry
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Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07419828
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ClinicalTrials.gov ID
NCT07419828
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: 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.

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

    Timeframe: month 36

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

    Timeframe: month 6

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

    Timeframe: month 60

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

  • 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%.

  • 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
Sources for eligibility
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  • National Clinical Research Center of Kidney Diseases, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing UniversityNanjing, ChinaRecruiting
Sources for sites
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (1)