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Clinical Trials in China / NCT06635772
Starting soon Phase 2

A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathy

NCT06635772 · tracked via the Priya Life Science China tracker
Sponsor
Hansoh BioMedical R&D Company
Phase
Phase 2
Started
2024-11
Last updated
2024-10-10

Condition(s) studied

Immunoglobulin a Nephropathy

Investigational drug(s) / intervention(s)

HS-10390Irbesartan

HS-10390: HS-10390 will be administered daily

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)

Trial sites (1)

FacilityCityRegionStatus
Peking University First Hospital Beijing China

On this site

📄 Avapro (irbesartan) drug profile →

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Official registry record

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.

View NCT06635772 on ClinicalTrials.gov ↗ ← All trials in China