A Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Primary IgA Nephropathy

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChengdu Suncadia Medicine Co., Ltd.

About this trial

This study aims to evaluate the long-term safety of HRS-5965 capsules in patients with primary IgA nephropathy, and also to assess its efficacy in reducing 24-hour urinary protein and delaying the decline in eGFR in these patients.

Eligibility criteria

Qualifiers

Patients with primary IgA nephropathy who completed treatment in Study HRS-5965-305, or who prematurely discontinued study drug during the maintenance phase following initiation of rescue therapy;

Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person.

Disqualifiers

Hypersensitivity to the study drug or its components;

History of immunodeficiency disorders;

History of invasive encapsulated bacterial infection;

History of malignant neoplasm;

Trial design

Treatments tested in this trial

  • HRS-5965 Capsules

Treatment groups

380 Participants
are divided into 1 treatment group