Table 2:
Collection of data during ZENITH-CKD.
| Screening | Dosing | Follow-up | ||||||
|---|---|---|---|---|---|---|---|---|
| Week: | –4 | 0 | 1 | 3 | 6 | 9 | 12 | 14 |
| Procedures | ||||||||
| Informed consent, demography | ✓ | |||||||
| Inclusion and exclusion criteria | ✓ | ✓ | ||||||
| Screening in IRT/RTSM | ✓ | |||||||
| Randomization in IRT/RTSM | ✓ | |||||||
| Physical exam | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Medical and surgical history | ✓ | |||||||
| Serology | ✓ | |||||||
| FSH/LH | ✓ | |||||||
| SARS-CoV-2 local test | ✓ | |||||||
| Concomitant medication | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Study intervention dispensed | ✓ | ✓ | ✓ | ✓ | ||||
| Study intervention account | ✓ | ✓ | ✓ | ✓ | ||||
| Study intervention intake at the clinic | ✓ | ✓ | ✓ | |||||
| Assessments | ||||||||
| Spot urine from first morning void: albumin and creatinine | ✓ | |||||||
| Spot urine from first morning void over three consecutive days: albumin and creatinine | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Spot urine from first morning void: Na+, K+, uric acid, urea, glucose, creatinine, osmolality and cortisol | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Body weight | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Echocardiography | ✓ | ✓ | ||||||
| Bioimpedance spectroscopy | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Daily digital body weight measurement (home-based) | Daily from (2 days before) randomization to end of follow-up | |||||||
| Plasma/serum K+, Na+, uric acid, BUN, fasting plasma glucose, cystatin C, haematocrit, haemoglobin, ET-1, ELDP, CT-proET-1, copeptin, NT-proBNP and BNP | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Adverse event review | ✓a | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Vital signs | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Digital 12-lead safety ECG | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Clinical chemistry and haematology | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Urinalysis | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| HbA1c, cholesterol and lipids | ✓ | ✓ | ✓ | ✓ | ||||
| Post-dose PK plasma sample | ✓ | ✓ | ✓ | |||||
| 4-h PK blood sample profile | ✓ | |||||||
| Pre-dose PK sample | ✓ | |||||||
| Exploratory metabolite evaluation | ✓ | |||||||
| Collect and store serum, plasma, and urine samples for exploratory assessment of biomarkers | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Optional genetic sampling (blood) | ✓ | |||||||
aSerious adverse events only.
BUN, blood urea nitrogen; ECG, electrocardiogram; FSH, follicle-stimulating hormone; HbA1c, glycated haemoglobin; IRT, interactive response technology; K+, potassium; LH, luteinizing hormone; Na+, sodium; NT-proBNP, N-terminal pro-B-type natriuretic peptide; PK, pharmacokinetic; RTSM, randomization and trial supply management; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.