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
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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