Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)

Study Overview
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Brief Summary
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The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Heart, Lung and Blood Institute (NHLBI) funded a cooperative agreement including two Clinical Coordinating Centers (at Children's Hospital of Philadelphia and at Children's Mercy Hospital in Kansas City), a central biochemistry laboratory (at the University of Rochester) and a Data Coordinating Center (at Johns Hopkins School of Public Health) to conduct a prospective epidemiological study of children with chronic kidney disease (CKD).

Detailed Description
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Since its inception in 2003, the scientific aims of CKiD have been to determine the risk factors for decline in kidney function and to define how progressive decline in kidney function impacts biomarkers of risk factors for cardiovascular disease; neurocognitive function and behavior; and growth failure and its associated morbidity.

Official Title
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Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)

Conditions
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Chronic Kidney Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 1 and 16 years (before 17th birthday) for Cohorts 1 and 2; age between 6 months and 16 years (before 17th birthday) for Cohort 3 Estimated (based on SCr) Schwartz GFR between 30 and 90 ml/min|1.73m2 for Cohort 1 OR an estimated GFR between 45 and 90 ml/min|1.73m2 based on the updated Schwartz formula for Cohort 2 Willingness and ability to provide informed consent and assent For Cohort 3, children with non-glomerular diagnosis and duration of kidney disease less than 5 years will be enrolled. Exclusion Criteria: Renal, other solid organ, bone marrow or stem cell transplantation Dialysis treatment within the past three months Cancer diagnosis or HIV diagnosis/treatment within last twelve months Current pregnancy or pregnancy within past twelve months Inability to complete major data collection procedures Current enrollment in a randomized clinical trial in which the specific treatment is unknown Not fluent in English or Spanish Plans to move out of area of any participating CKiD site (Families can be transferred to another CKiD site if they move) History of structural heart disease Genetic syndromes involving the central nervous system (e.g., Downs syndrome) History of severe to profound mental retardation (i.e., intelligence quotient (IQ)<40, significant impairment in adaptive function and/or inability to independently execute self-care skills) For cohort 3, children who are expected to receive renal replacement therapy within 6 months of date of enrollment will not be recruited

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Age between 1 and 16 years (before 17th birthday) and estimated (based on SCr) Schwartz GFR between 30 and 90 ml/min|1.73m2 | |
| Cohort 2<br>Age between 1 and 16 years (before 17th birthday), estimated GFR between 45 and 90 ml/min|1.73m2 based on the updated Schwartz formula, and an equal distribution of children with glomerular and non-glomerular causes of disease were enrolled (i.e., 150 within each) and the study placed an upper limit of 60% for the percent of enrolled with non-glomerular disease. | |
| Cohort 3<br>Age between 6 months and 16 years (before 17th birthday) with non-glomerular diagnosis and duration of kidney disease less than 5 years will be enrolled. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Kidney Replacement Therapy | The time to Kidney Replacement Therapy (KRT) is assessed as the date of diagnosis to the date of KRT. The exact KRT date is self-reported by the participant and confirmed by medical record abstraction. | Annually up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decline in Glomerular filtration rate (GFR) ml/min | Define and identify novel and traditional risk factors for the accelerated decline of GFR at regular annual study visits. | Up to 20 years |