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

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

Overview

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.

Interventions

• Drug HRS-1780 tablets
  Oral tablets
• Drug Placebo
  Oral tablets

Primary outcome measures

• Time to the first appearance of the composite endpoint: [Time frame: month 60]

Secondary outcome measures (3)

• The annualized total slope of eGFR from baseline to 36 months. [Time frame: month 36]
• The ratio of UACR to baseline at the 6th month . [Time frame: month 6]
• The proportion of participants whose UACR decreased by at least 30% relative to the baseline by the end of treatment. [Time frame: month 60]

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≥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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• National Clinical Research Center of Kidney Diseases, Jinling Hospital, Affiliated Hospita — Nanjing

Identifiers

NCT: NCT07419828 · HRS-1780-301

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗