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

A Randomized, Multicenter, Open-label, Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Immunoglobulin a Nephropathy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Immunoglobulin a Nephropathy
• Intervention / Treatment: Drug: HS-10390; Drug: Irbesartan

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: jicheng Lv, PhD; Phone Number: +8613161753111; Email: chenglv@263.net

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS-10390; high dose	Drug: HS-10390; HS-10390 will be administered daily
Experimental: HS-10390; low dose	Drug: HS-10390; HS-10390 will be administered daily
Active Comparator: 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	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in 24-hour urine protein at Week 12	The change in urine protein: creatinine ratio (UPCR) from baseline to Week 12	up to week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in 24-hour urine protein (UPCR)	The change in urine protein: creatinine ratio (UPCR) from baseline	up to Week 12
Change from baseline in 24-hour urine protein(UACR)	The change in urine albumin: creatinine ratio (UACR) from baseline	up to Week 12
Change from baseline in 24-hour urine protein	The change in urine protein excretion from baseline	up to Week 12
Proportion Change from baseline in 24-hour urine protein	The proportion of patients with urinary protein equivalent of < 0.3 g/24 hours	up to Week 12
change from baseline in Estimated Glomerular Filtration Rate	change from baseline in Estimated Glomerular Filtration Rate (eGFR)	up to Week 12
Number of subjects with adverse events (AEs)	Type, incidence, severity, seriousness, and relatedness of AEs will be collected	up to Week 12
Plasma Concentration of HS-10390	Blood samples will be collected for the measurement of plasma concentrations of HS-10390	up to Week 12

Collaborators and Investigators

• Sponsor: Hansoh BioMedical R&D Company

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Immunoglobulin A Nephropathy
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Glomerulonephritis, IGA; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Irbesartan
• Other Study ID Numbers: HS-10390-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No