A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathy
Phase 2
Not yet recruiting
- Conditions
- Immunoglobulin a Nephropathy
- Interventions
- Registration Number
- NCT06635772
- Lead Sponsor
- Hansoh BioMedical R&D Company
- Brief Summary
This study will evaluate the efficacy and safety of HS-10390 in subjects with primary IgA nephropathy, and explore the optimal dose for the treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- Male or female, between 18 and 65 years age.
- Biopsy-proven primary IgA nephropathy.
- Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (the patient's maximum tolerated dose and is at least one-half of the maximum labeled dose).
- Average 24-hour urine total protein ≥ 0.75 g/24 h at screening.
- Estimated GFR (using the CKD-EPI 2009) ≥ 30 mL/min per 1.73 m^2 at screening.
- Systolic BP between 100 and 150 mmHg and diastolic BP between 60 and 100 mmHg.
Exclusion Criteria
- IgA nephropathy secondary to another condition
- IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;
- Chronic kidney disease (CKD) in addition to IgAN
- Patients treated with any systemic non-biologic immunosuppressive drugs (including systemic corticosteroids) within 12 weeks prior to randomizing；
- Require any prohibited medications prior to randomizing;
- Exposure to an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening
- History of organ transplantation, with exception of corneal transplants
- Platelet< 100×109/L or hemoglobin value < 90 g/L) or Hematocrit value < 27% (0.27 V/V) at Screening
- Elevations of transaminases (ALT and/or AST) >2 times upper limit of normal or total bilirubin and/or direct bilirubin exceeding 1.5 times the upper limit of normal (ULN) at screening
- Potassium >5.5 mmol/L at Screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HS-10390; high dose HS-10390 HS-10390; high dose HS-10390; low dose HS-10390 HS-10390; low dose irbesartan Irbesartan Irbesartan will be administered daily as a 150-mg oral tablet. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg
- Primary Outcome Measures
Name Time Method Change from baseline in 24-hour urine protein at Week 12 up to week 12 The change in urine protein: creatinine ratio (UPCR) from baseline to Week 12
- Secondary Outcome Measures
Name Time Method Change from baseline in 24-hour urine protein (UPCR) up to Week 12 The change in urine protein: creatinine ratio (UPCR) from baseline
Change from baseline in 24-hour urine protein(UACR) up to Week 12 The change in urine albumin: creatinine ratio (UACR) from baseline
Change from baseline in 24-hour urine protein up to Week 12 The change in urine protein excretion from baseline
Proportion Change from baseline in 24-hour urine protein up to Week 12 The proportion of patients with urinary protein equivalent of \< 0.3 g/24 hours
change from baseline in Estimated Glomerular Filtration Rate up to Week 12 change from baseline in Estimated Glomerular Filtration Rate (eGFR)
Number of subjects with adverse events (AEs) up to Week 12 Type, incidence, severity, seriousness, and relatedness of AEs will be collected
Plasma Concentration of HS-10390 up to Week 12 Blood samples will be collected for the measurement of plasma concentrations of HS-10390