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

NCT06635772 | Not Yet Recruiting Phase 2

• 1 other identifier: HS-10390-201
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunoglobulin a Nephropathy

Keywords

Immunoglobulin A Nephropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from baseline in 24-hour urine protein (UPCR)

  up to Week 12

• Change from baseline in 24-hour urine protein(UACR)

  up to Week 12

• Change from baseline in 24-hour urine protein

  up to Week 12

• Proportion Change from baseline in 24-hour urine protein

  up to Week 12

• change from baseline in Estimated Glomerular Filtration Rate

  up to Week 12

Study Arms (3)

HS-10390; high dose

EXPERIMENTAL

HS-10390; high dose

Drug: HS-10390

HS-10390; low dose

EXPERIMENTAL

HS-10390; low dose

Drug: HS-10390

irbesartan

ACTIVE COMPARATOR

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

Interventions

HS-10390 DRUG

HS-10390 will be administered daily

HS-10390; high dose; HS-10390; low dose

Irbesartan DRUG

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

irbesartan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Central Study Contacts

jicheng Lv, PhD

CONTACT

+8613161753111; chenglv@263.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 30, 2026
• Last Updated: October 10, 2024

Record last verified: 2024-10

Locations

CN (1)