NCT07582133RecruitingPhase 2
A Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Primary IgA Nephropathy
A Multicenter, Open-label Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 Capsules in Patients With Primary IgA Nephropathy
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 380 (estimated)
- First submitted
- 6 May 2026
- Start date
- 6 Jul 2026
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.
- Diseases
- IgA nephropathy
- NCT number
- NCT07582133
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 380
- From 6 Jul 2026 to the primary completion date, 31 Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hypersensitivity to the study drug or its components;
- History of immunodeficiency disorders;
- History of invasive encapsulated bacterial infection;
- History of malignant neoplasm;
Lab values
- The estimated glomerular filtration rate (eGFR) is less than 20 mL/min/1.73m2;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.