Primary IgA Nephropathy
Conditions
Brief summary
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
HRS-5965 Capsules
Sponsors
Chengdu Suncadia Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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；
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events (AEs) throughout the study; | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Ratio of 24-hour urine protein excretion (24-UPE) to baseline; | 2 years |
| The change from baseline in estimated glomerular filtration rate (eGFR); | 2 years |
| The change from baseline in serum creatinine (Scr); | 2 years |
| The proportion of participants with 24-UPE < 0.5 g/d; | 2 years |
| The proportion of participants with 24-UPE < 0.3 g/d; | 2 years |
Countries
China
Contacts
CONTACTYanfang Zou
Outcome results
None listed