Table 3.
Area | Measurement | Follow-Up Month |
|||||
---|---|---|---|---|---|---|---|
0 | 3 to 6 | 12 | 24 | 36 | 48 | ||
General | Physical examination/medical history | X | X | X | X | X | X |
Medication use | X | X | X | X | X | X | |
Symptoms checklist | X | X | X | X | X | X | |
Kidney | Iohexol-based GFR | X | X | X | |||
Central renal panel | X | X | X | X | X | ||
Central urine creatinine, proteinb | X | X | X | X | X | ||
Cystatin C–based GFR | X | X | X | ||||
HPLC serum creatinine | X | X | X | X | X | ||
Local basic metabolic panel | X | X | X | X | X | ||
Local urine creatinine, proteinb | X | X | X | X | X | ||
Local complete blood count | X | X | X | X | X | ||
Local pregnancy test | X | X | X | X | X | ||
Cardiovascular | Echocardiography | X | X | ||||
ABPM | X | X | |||||
Carotid IMTc (n = 30) | X | X | |||||
Lipid profile | X | X | |||||
Clinical BP | X | X | X | X | X | X | |
Neurocognitive | Pediatric quality of life | X | X | X | X | X | |
Cognitive and development | X | X | X | ||||
Behavioral assessment | X | X | X | ||||
Magnetic resonance imaged (n = 30) | X | X | X | ||||
Neuropsychological assessmentsd (n = 30) | X | X | X | ||||
Growth and nutrition | Height or length | X | X | X | X | X | X |
Weight | X | X | X | X | X | X | |
Head and mid-arm circumference | X | X | X | X | X | X | |
Tanner stage | X | X | X | X | X | X | |
3-d diet record, food frequency | X | X | X | X | X | ||
Physical activity | X | X | X | X | X | ||
Inflammation | Wide-range C-reactive protein | X | X | ||||
Bone health | Intact PTH | X | X | X | |||
Bone biopsyc (n = 10) | X | X |
ABPM, ambulatory BP monitoring; IMT, intima-media thickness; PTH, parathyroid hormone.
First morning urine specimen collection.
Subcohort studies for carotid IMT and bone biopsy at select sites with technical capability to perform the specific tests.
High-risk neurocognitive testing and imaging will be performed at three sites with specific imaging capabilities in children who are older than 9 yr and have GFR <40 ml/min per 1.73 m2. High-risk neurocognitive assessment includes Children’s Memory Scale (CMS), Delis-Kaplan Executive Function System (D-KEFS), Benton Judgment of Line Orientation and Form Discrimination (Benton), and Clinical Evaluation of Language Fundamentals, Fourth Edition (CELF-4).