A Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Primary IgA Nephropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-5965 Capsules.
- Who it may be relevant to
- Registry conditions: Primary IgA Nephropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open-label Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 Capsules in Patients With Primary IgA Nephropathy
Overview
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.
Interventions
- Drug HRS-5965 Capsules
HRS-5965 Capsules
Primary outcome measures
- The incidence and severity of adverse events (AEs) throughout the study; [Time frame: 2 years]
Secondary outcome measures (5)
- Ratio of 24-hour urine protein excretion (24-UPE) to baseline; [Time frame: 2 years]
- The change from baseline in estimated glomerular filtration rate (eGFR); [Time frame: 2 years]
- The change from baseline in serum creatinine (Scr); [Time frame: 2 years]
- The proportion of participants with 24-UPE < 0.5 g/d; [Time frame: 2 years]
- The proportion of participants with 24-UPE < 0.3 g/d; [Time frame: 2 years]
Eligibility criteria
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；
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University First Hospital — Beijing
Identifiers
NCT: NCT07582133 · HRS-5965-206