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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.
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University First Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.