This is a multicenter, open-label study to evaluate the long-term safety and efficacy of FXS6837 capsules in primary IgAN patients. About 60 IgAN patients who had received and completed FXS6837-IIb-201 study treatment will be enrolled to take FXS6837 capsules orally according to protocol for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
FXS6837 capsule orally taken according to protocol for 2 years
Peking University First Hospital
Beijing, Beijing Municipality, China
Incidence and severity of adverse events
Time frame: through study completion, an average of 2 years
Ratio of urine protein-to-creatinine ratio (UPCR) to baseline at each visit
Time frame: through study completion, an average of 2 years
Ratio of urine albumin-to-creatinine ratio (UACR) to baseline at each visit
Time frame: through study completion, an average of 2 years
Ratio of 24-h urine protein (24 hour-UPE) to baseline at each visit
Time frame: through study completion, an average of 2 years
Ratio of 24-h urine albumin excretion (24 hour-UAE) to baseline at each visit
Time frame: through study completion, an average of 2 years
Change from baseline in estimated glomerular filtration rate (eGFR) at each visit
Time frame: through study completion, an average of 2 years
Trough plasma concentration of FXS6837
Time frame: through study completion, an average of 2 years
Complement AP activity in peripheral blood at each visit point
Time frame: through study completion, an average of 2 years
Levels and changes of PD biomarkers in plasma and urine at each visit
Time frame: through study completion, an average of 2 years
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