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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChengdu Suncadia Medicine Co., Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Hypersensitivity to the study drug or its components;

History of immunodeficiency disorders;

History of invasive encapsulated bacterial infection;

History of malignant neoplasm;

Trial design

Design model

Single group

Treatments tested in this trial

  • HRS-5965 Capsules

    Drug

    HRS-5965 Capsules

Treatment groups

380 Participants
are divided into 1 treatment group
Group A: HRS-5965 CapsulesExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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