Immunoglobulin a Nephropathy
Conditions
Keywords
Immunoglobulin A Nephropathy
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.
Interventions
DRUGHS-10390
HS-10390 will be administered daily
DRUGIrbesartan
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
Sponsors
Hansoh BioMedical R&D Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 24-hour urine protein (UPCR) | up to Week 12 | The change in urine protein: creatinine ratio (UPCR) from baseline |
| 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 |
| change from baseline in Estimated Glomerular Filtration Rate | up to Week 12 | change from baseline in Estimated Glomerular Filtration Rate (eGFR) |
Countries
China
Contacts
Primary Contactjicheng Lv, PhD
Outcome results
None listed