Table 1.
Name of Outcome | Specific Measure | Timepoints | Powered | |
---|---|---|---|---|
Primary | Kidney function decline composite | Composite event of 50% reduction in eGFR, kidney replacement therapy, or eGFR < 15 mL/min/1.73 m2 | From CED to end of follow-up | Yes |
Secondary | Patient-reported outcome profile | PROMIS Pediatric measures for fatigue, pain, sleep health, anxiety, life satisfaction, and peer relationships Other measures of health status deemed important by parent and youth partners; experience with home BP monitoring |
Single time point (date of patient survey) | Yes |
Secondary | GFR trajectory | Change in eGFR per unit time | From CED to end of follow-up | Yes |
Exploratory | BP treatment adverse events | Diagnosis-based adverse events: hypotension, dizziness, cough, stomatitis, tonsillitis, urinary tract infection, nocturnal enuresis, gastrointestinal symptoms, fatigue, edema, hair loss, respiratory tract infection, pyelonephritis, headache, pericarditis, syncope Laboratory-based adverse events: hyperkalemia, increase in liver enzymes, leukocytopenia, anemia, acidosis Other adverse events: death, ED visit for hypertension, hospitalization for hypertension |
From CED to end of follow-up | No |
Abbreviations: BP, blood pressure; CED, cohort entrance date; ED, emergency department; eGFR, estimated glomerular filtration rate.