Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
QD or BID, 24-weeks fixed dose.
24-weeks fixed dose.
24-weeks fixed dose.
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGNanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGThe ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 12 weeks of treatment
Time frame: From week 1 to week 12
The ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 24 weeks of treatment
Time frame: From week 1 to week 24
The ratio of 24h-UPCR compared to baseline at each clinical visit point during the treatment period
Time frame: From week 1 to week 24
The ratio of 24-hour urine protein (24h-UPE) compared to baseline at each clinical visit point during the treatment period
Time frame: From week 1 to week 24
The change in estimated glomerular filtration rate (eGFR, CKD-EPI 2021 formula) compared to baseline at each clinical visit point during the treatment period
Time frame: From week 1 to week 24
The change in blood creatinine compared to baseline at each clinical visit point during the treatment period
Time frame: From week 1 to week 24
The ratio of FMV UPCR, urinary albumin to creatinine ratio (UACR) compared to baseline at each clinical visit point during the treatment period
Time frame: From week 1 to week 24
The change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale score compared to baseline at each clinical visit point during the treatment period
0-52, the higher the score, the better the QOL.
Time frame: From week 1 to week 24
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24-weeks fixed dose.
Incidence , severity and relationship of adverse events during the study period
Time frame: From week 1 to week 24
Plasma Pharmacokinetics (PK) of Time to Maximum Concentration at Steady State (Tmax,ss) of HSK39297
Time frame: From week 1 to week 24
Plasma Pharmacokinetics (PK) of Area Under the Curve at Steady State (AUCtau,ss and AUClast,ss) of HSK39297
Time frame: From week 1 to week 24
Plasma Pharmacokinetics (PK) of Pre-dose Trough at Steady State (Ctrough,ss) of HSK39297
Time frame: From week 1 to week 24
Plasma Pharmacokinetics (PK) of Maximum Concentrations (Cmax,ss) at Steady State of HSK39297
Time frame: From week 1 to week 24
Changes in alternative pathway (AP) complement activity compared to baseline at each clinical visit point during the treatment period
Time frame: From week 1 to week 24
Changes in plasma Bb levels compared to baseline at each clinical visit point during the treatment period
Time frame: From week 1 to week 24
Changes in plasma and urine sC5b-9 levels compared to baseline at each clinical visit point during the treatment period
Time frame: From week 1 to week 24