About this trial
Efficacy and safety of MY008211A in IgAN patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males or females ≥ 18 and ≤ 75 years of age at Screening.
Estimated GFR(eGFR) ≥30 mL/min/1.73m2.
Subjects with a biopsy-confirmed diagnosis of IgAN.
Urine protein ≥0.75 g/24h from a 24h urine collection.
Disqualifiers
Systolic blood pressure >130 mm Hg or diastolic blood pressure >80 mm Hg.
Presence of any secondary IgAN.
Presence of rapidly progressive glomerulonephritis.
Presence of other chronic kidney diseases.
Trial design
Parallel
Treatments tested in this trial
MY008211A tablets
DrugMY008211A BID
MY008211A tablets matched placebo
DrugMatching placebo to MY008211A taken twice a day.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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