Health TrialsbyHealthPanel

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

ConditionChronic 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HS-10390

    Drug

    HS-10390

  • HS-10390

    Drug

    HS-10390

  • HS-10390

    Drug

    HS-10390

  • Irbesartan

    Drug

    Target dose of 300 mg daily

Treatment groups

182 Participants
are divided into 4 treatment groups
Group A: HS-10390 Dose AExperimental treatment 1 intervention
Group B: HS-10390 Dose BExperimental treatment 1 intervention
Group C: HS-10390 Dose CExperimental treatment 1 intervention
Group D: IrbesartanActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

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)
2

Change in Urine Protein/Creatinine Ratio (UPCR) From Baseline at Each Visit

Time frame
From baseline (Day 1) at each visit
3

Change in 24 hour Urinary Protein Excretion From Baseline at Each Visit

Time frame
From baseline (Day 1) at Each Visit
4

Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Each Visit

Time frame
From baseline (Day 1) at Each Visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: