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NCT Number: NCT07582133

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

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.

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Key information

Conditions

Primary IgA Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100000, China

Location status: Recruiting

Location contact

Hong Zhang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

HRS-5965 Capsules

Drug

HRS-5965 Capsules

Primary outcomes

  1. The incidence and severity of adverse events (AEs) throughout the study;

    Time frame: 2 years

Secondary outcomes

  1. Ratio of 24-hour urine protein excretion (24-UPE) to baseline;

    Time frame: 2 years

  2. The change from baseline in estimated glomerular filtration rate (eGFR);

    Time frame: 2 years

  3. The change from baseline in serum creatinine (Scr);

    Time frame: 2 years

  4. The proportion of participants with 24-UPE < 0.5 g/d;

    Time frame: 2 years

  5. The proportion of participants with 24-UPE < 0.3 g/d;

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Yanfang Zou

CONTACT

[email protected]

+0518-82342973

Sponsors and collaborators

Lead sponsor

Chengdu Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 12, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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