Item | Screening visit | V1 | V2 | V3 | V4 | V5 | V6 |
---|---|---|---|---|---|---|---|
Visit | |||||||
Time | −1w | 0w ± 7d | 4w ± 7d | 12w ± 7d | 24w ± 7d | 36w ± 7d | 48w ± 7d |
Confirm eligibility | √ | √ | |||||
Written informed consent | √ | ||||||
Clinical and demographic information | √ | √ | |||||
Physical examination | √ | √ | √ | √ | √ | √ | √ |
Signs and symptoms | √ | √ | √ | √ | √ | √ | √ |
24-h urinary proteinuria | √ | √ | √ | √ | √ | √ | √ |
24-h urine creatinine | √ | √ | √ | √ | √ | √ | √ |
Routine urine test | √ | √ | √ | √ | √ | √ | √ |
Urine pregnancy test | √ | ||||||
Routine blood test | √ | √ | √ | √ | √ | √ | |
Blood biochemical tests | √ | √ | √ | √ | √ | √ | |
eGFR | √ | √ | √ | √ | √ | √ | √ |
Serum cystatin C and high-sensitivity C-reactive protein | √ | √ | √ | ||||
Electrocardiogram and | √ | √ | |||||
Chest X-ray examinations | √ | √ | |||||
Drug distribution | √ | √ | √ | √ | √ | ||
Drug combination | √ | √ | √ | √ | √ | √ | |
Adverse event | √ | √ | √ | √ | √ | ||
Exit criteria assessment | √ | √ | √ | √ | √ |