V0 | V1 | V2 | V3 | V4 | V5 | V6 | V7 | V8 | V9 | V10 | V11 | V12/early termination | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Items | (−4 weeks) | (−2 weeks) | (0 months) | (1 months) | (2 months) | (3 months) | (6 months) | (9 months) | (12 months) | (15 months) | (18 months) | (21 months) | (24 months) |
Informed consent | X | ||||||||||||
Inclusion/exclusion criteria | X | X | |||||||||||
Demographic data | X | ||||||||||||
Medical history | X | ||||||||||||
Randomisation | X | ||||||||||||
Safety evaluation | |||||||||||||
Physical examination | X | X | X | X | X | X | X | X | X | X | X | X | X |
Vital signs | X | X | X | X | X | X | X | X | X | X | X | X | X |
CKD classification | X | X | X | X | X | X | X | X | X | X | |||
Electrocardiography | X | X | X | X | X | X | X | X | X | X | |||
Adverse events | X | X | X | X | X | X | X | X | X | X | X | X | X |
Drug combination | X | X | X | X | X | X | X | X | X | X | X | X | X |
Laboratory tests | |||||||||||||
Blood cellular evaluation | X | X | X | X | X | X | X | X | X | X | X | X | |
Blood biochemical analysis | X | X | X | X | X | X | X | X | X | X | X | X | |
Serum electrolytes | X | X | X | X | X | X | X | X | X | X | X | X | |
Routine urine test | X | X | X | X | X | X | X | X | X | X | X | X | |
24 hour urine protein | X | X | X | X | X | X | X | X | X | X | X | X | |
Urinary albumin /creatinine ratio | X | X | X | X | X | X | X | X | X | X | X | X | |
Therapeutic effect evaluation | |||||||||||||
eGFR | X | X | X | X | X | X | X | X | X | X | X | X | |
Blood pressure (BP)* | X | X | X | X | X | X | X | X | X | X | X | X | X |
Proteinuria | X | X | X | X | X | X | X | X | X | X | X | X | |
Fosinopril dispensed | X | X | X | X | X | X | X | X | X | X | X | X | |
Benidipine and hydrochlorothiazide dispensed | X | X | X | X | X | X | X | X | X | X | |||
Drugs collected | X | X | X | X | X | X | X | X | X | X | X | X |
*The first BP measurement will be taken before patients receive antihypertensive treatment. The mean BP of three measurements should be recorded.
CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate.