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

Chengdu Suncadia Medicine

Status and phase: Not yet enrolling; Phase 2

Conditions: Primary IgA Nephropathy

Treatments: Drug: HRS-5965 Capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT07582133

HRS-5965-206

Details and patient eligibility

About

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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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;
2. Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person.

Exclusion criteria

1. Hypersensitivity to the study drug or its components；
2. History of immunodeficiency disorders；
3. History of invasive encapsulated bacterial infection；
4. History of malignant neoplasm；
5. The estimated glomerular filtration rate (eGFR) is less than 20 mL/min/1.73m2；

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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380 participants in 1 patient group

HRS-5965 Capsules

Experimental group

Treatment:

Drug: HRS-5965 Capsules