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

May 6, 2026 updated by: Chengdu Suncadia Medicine Co., Ltd.

A Multicenter, Open-label Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 Capsules 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

380

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Peking University First Hospital
        • Principal Investigator:
          • Hong Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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；

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRS-5965 Capsules
Drug: HRS-5965 Capsules
HRS-5965 Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence and severity of adverse events (AEs) throughout the study;
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Ratio of 24-hour urine protein excretion (24-UPE) to baseline;
Time Frame: 2 years
2 years
The change from baseline in estimated glomerular filtration rate (eGFR);
Time Frame: 2 years
2 years
The change from baseline in serum creatinine (Scr);
Time Frame: 2 years
2 years
The proportion of participants with 24-UPE < 0.5 g/d;
Time Frame: 2 years
2 years
The proportion of participants with 24-UPE < 0.3 g/d;
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Suncadia Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-5965-206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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