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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHansoh BioMedical R&D Company

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • HS-10390
  • Irbesartan

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators