Efficacy and safety of MY008211A in IgAN patients
This was a multicenter, randomized, double-blind, dose-ranging, parallel-group study. Two doses of MY008211A (200mg, 400mg) were compared with placebo. The study comprised a screening period of this study for 90 days, an efficacy observation period for 24 weeks, a long-term study for 80 weeks, and a follow-up period for 2 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
MY008211A BID
Matching placebo to MY008211A taken twice a day.
Peking University First Hospital
Beijing, Beijing Municipality, China
The ratio of urine protein to creatinine concentration ratio (UPCR based on 24h urine collection, 24h-UPCR) relative to baseline at Week 12.
Participants collected their urine over a 24-hour period.
Time frame: Week 12
The ratio of 24 h-UPCR relative to baseline at each visit during treatment period except Week 12.
Participants collected their urine over a 24-hour period.
Time frame: up to 24 weeks
The ratio of 24-hour urine protein excretion (24 h-UPE) relative to baseline at each visit during treatment period.
Participants collected all of their urine over a 24-hour period.
Time frame: up to 24 weeks
The ratio of 24-hour urine albumin (24 h-UA) relative to baseline at each visit during treatment period.
Participants collected all of their urine over a 24-hour period.
Time frame: up to 24 weeks
The ratio of 24-hour urine albumin to creatinine concentration ratio (24 h-UACR) relative to baseline at each visit during treatment period.
Participants collected all of their urine over a 24-hour period.
Time frame: up to 24 weeks
Change from baseline in serum creatinine at each visit during treatment period.
Serum creatinine
Time frame: up to 24 weeks
Change from baseline in estimated glomerular filtration rate (eGFR) at each visit during treatment period.
eGFR was calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
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Time frame: up to 24 weeks