CKiD Study Design
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Transcript of CKiD Study Design
CKiD Study Design• Observational Cohort Study
- 5 year study (Oct 2003 – Jul 2008)
5 year renewal (Aug 2008 – Jul 2013)
- Enrollment period: Apr 2005 – Mar 2008
• 560 Children
- Mild to moderately impaired kidney
function
- Age between 1 and 16 yearsDCC: Munoz, JHU BSPH, Baltmore; CCC’s: PI’s Furth, JHU, Baltimore& Warady, CMH, KansasCity; Central Lab: Schwartz, U Rochester
CKiD Study Goals
0 Time
En rollmen t eligible eGFR
CKD
15
30
60
90
GFR
ESRD
NonprogressorProgressorFast progressor
3May 09
• Define risk factors for CKD progression
• Define effects of CKD progression on:
- Neurocognitive development/function
- Prevalence of CVD risk factors
- Growth failure
CKiD Measurements According to Time-on-Study
Enrollment
Year 1 Year 2 Year 3 Year 4 Year 5 Year 6
GFR (Iohexol) (3 pt)
Cystatin C (q visit)
Echo, ABPM, Carotid IMTa, Lipids
wrCRP, iPTH, Vitamin D, FFQDEXA Scana, Bone Agea
Measurements
Kidney:, Renal Panel*, CBC*, proteinuria, albuminuria
CV: Standardized BP*
Growth: Height*, Weight*,
Tanner Stage*, Waist & Hip Circumference*
*Locally performed tests
PedsQOL, Cognitive, Behavior Tests,MRIa, High Risk Assessmentsa
aSubcohort 4 CKiD
CKiD Cohort N=560 Variable Median or %
Age, yrs 11.0Male sex 62%Child’s Race Caucasian 70%
African American 21%
Other race 4% More than
one race 5%
Hispanic Ethnicity 15%
Income < $36k 40% $36k-75k 31% > 75K 28%
Variable Median or %
CKD Cause
Glomerular 21%Urologic/
Hereditary 79%Age of CKD Onset (yrs) 0.8
Years with CKD 6.4
Prematurity 24%Low BWa 19%VL BWb 9%
a LBW: <2500g, US Rate=7.9%
b VLBW: <1500g, US Rate=1.4%
Data Source: SC Meeting 1/09
Ancillary Studies- Process
CKiD-I
IRB (Local)
Concept Sheet to DCC
DCC SC
Scientific Subcommittee
Approve/Disapprove within 4 weeks