A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney… (NCT07555054) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney Disease
China182 participantsStarted 2026-05-21
Plain-language summary
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
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Men and women aged 18-70 years old;
✓. Body mass index (BMI) ≥18.0 and \<50.0 kg/m\^2 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 m\^2 calculated using the 2021 CKD-EPI creatine formula at screening;
✓. Urinary albumin/creatinine ratio (UACR) was ≥300 and \<3000 mg/g for at least 2 times on different days detected by the local laboratory at screening;
✓. Systolic BP between 90 and 160 mmHg and diastolic BP between 60 and 100 mmHg;
✓. Agree to contraception.
Exclusion criteria
✕. 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%);
What they're measuring
1
Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12
Timeframe: Frame: From baseline (Day 1) until Week 12 (Day 85)