Not yet recruiting NCT07555054
A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HS-10390, HS-10390, HS-10390, Irbesartan.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Multicenter, Double-blind, Parallel Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Participants With Chronic Kidney Disease
Overview
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
Interventions
- Drug HS-10390
HS-10390 - Drug HS-10390
HS-10390 - Drug HS-10390
HS-10390 - Drug Irbesartan
Target dose of 300 mg daily
Primary outcome measures
- Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12 [Time frame: Frame: From baseline (Day 1) until Week 12 (Day 85)]
Secondary outcome measures (6)
- Proportion of participants achieving ≥20%, ≥30%, and ≥40% reduction in UACR from baseline at week 12 [Time frame: From baseline (Day 1) until Week 12 (Day 85)]
- Change in Urine Protein/Creatinine Ratio (UPCR) From Baseline at Each Visit [Time frame: From baseline (Day 1) at each visit]
- Change in 24 hour Urinary Protein Excretion From Baseline at Each Visit [Time frame: From baseline (Day 1) at Each Visit]
- Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Each Visit [Time frame: From baseline (Day 1) at Each Visit]
- Change in Office Systolic and Diastolic Blood Pressure From Baseline at Each Visit [Time frame: From baseline (Day 1) at Each Visit]
- Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) [Time frame: From screening until Follow-up visit (Day 98)]
Eligibility criteria
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%);
- Received any other study drug treatment within 30 days or 5 half-lives (whichever is longer) prior to screening;
- Polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, acute glomerulonephritis, bilateral renal artery stenosis;
- Acute kidney injury or dialysis treatment within 6 months before screening;
- Received kidney transplant, or plan to receive kidney transplant during the trial;
- Platelet< 100×10\^9/L or hemoglobin value < 90 g/L or Hematocrit value < 27% (0.27 V/V) at screening;
- Elevations of transaminases (ALT and/or AST) >3 times upper limit of normal (ULN) or total bilirubin exceeding 1.5 times the upper limit of normal at screening;
- Serum potassium >5.5 mmol/L at 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
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital,Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT07555054 · HS-10390-202