NCT07555054Not yet recruitingPhase 2
A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney Disease
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
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 182 (estimated)
- First submitted
- 21 Apr 2026
- Start date
- May 2026
- Primary completion date
- Nov 2027
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Diseases
- Chronic kidney disease
- NCT number
- NCT07555054
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 182
- From May 2026 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 ;
- Received any other study drug treatment within 30 days or 5 half-lives (whichever is longer) prior to screening;
- Acute kidney injury or dialysis treatment within 6 months before screening;
- Received kidney transplant, or plan to receive kidney transplant during the trial;
Other illness
- A known or suspected allergy to the investigational medical drug or its components or excipients;
Lab values
- Participants with uncontrolled diabetes mellitus (HbA1c \> 8%);
- Polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, acute glomerulonephritis, bilateral renal artery stenosis;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.