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