A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney Disease

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

The purpose of the study was to evaluate the efficacy and safety of HS-10390 in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 30 and \<90 mL/min/1.73 m\^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g and \< 3000 mg/g

Eligibility criteria

Qualifiers

Men and women aged 18-70 years old;

Body mass index (BMI) ≥18.0 and <50.0 kg/m² at screening;

Currently on stable dose (maximum tolerated dose and at least one-half of the maximum labeled dose) of ACEI and/or ARB therapy for at least 4 weeks and treated for at least 3 months prior to the screening visit;

Diagnosed with chronic kidney disease, and the estimated glomerular filtration rate (eGFR) was ≥30 and <90 mL/min/1.73 m² calculated using the 2021 CKD-EPI creatine formula at screening;

Disqualifiers

A known or suspected allergy to the investigational medical drug or its components or excipients;

Within 4 weeks before screening, the following drugs could not maintain the stable regimen: diabetes drugs, hypertension drugs, non-steroidal anti-inflammatory drugs;

If glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are prescribed, the dose are unstable within 8 weeks before screening ;

Participants with uncontrolled diabetes mellitus (HbA1c > 8%);

Trial design

Treatments tested in this trial

  • HS-10390
  • HS-10390
  • HS-10390
  • Irbesartan

Treatment groups

182 Participants
are divided into 4 treatment groups