This is a Phase II, multicenter, open-label study. Eligible subjects who have completed the HSK39297-202 study will be enrolled.Starting dose is 200 mg QD.Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains \>1 g/24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.After the treatment period, subjects will enter the 4-week safety follow-up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
73
Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains \>1 g/24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.
Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains \>1 g/24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.
Peking University First Hospital
Beijing, China
COMPLETEDPeking University First Hospital
Beijing, China
RECRUITINGIncidence and severity of adverse events (AEs) during treatment.
Time frame: 48 weeks
Ratio of 24-h urine protein-to-creatinine ratio (24h-UPCR) from baseline every 12 weeks during treatment
Time frame: 48 weeks
Ratio of 24-h urine protein excretion (24h-UPE) from baseline every 12 weeks during treatment
Time frame: 48 weeks
Change in estimated glomerular filtration rate (eGFR) from baseline every 24 weeks during treatment.
Time frame: 48 weeks
Proportion of subjects with hematuria every 12 weeks during treatment.
Time frame: 48 weeks
Change in Functional Assessment of Chronic Illness FACIT-F(Functional Assessment of Chronic Illness Therapy-Fatigue)score from baseline every 12 weeks during treatment
The scale consists of 13 items, assessing patients' fatigue levels over the past seven days as well as fatigue impacts on cognition, physical function, psychology and social interaction. The total score is the sum of scores for all items, ranging from 0 to 52. A higher score indicates a lower degree of fatigue.
Time frame: 48 weeks
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