Clinical Trials in China / NCT07582133
Recruiting
Phase 2
A Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Primary IgA Nephropathy
NCT07582133 · tracked via the Priya Life Science China tracker
Condition(s) studied
Primary IgA Nephropathy
Study summary
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
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；
Primary outcome measure(s)
- The incidence and severity of adverse events (AEs) throughout the study; — 2 years
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | Recruiting |
More Chengdu Suncadia Medicine Co., Ltd. trials in China
A Clinical Study of HRS-8797 in Healthy Participants
Starting soon
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07582133 on ClinicalTrials.gov ↗ ← All trials in China