Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)

Johns Hopkins Bloomberg School of Public Health

Status: Enrolling

Conditions: Chronic Kidney Disease

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00327860

IRB10007880 (Other Identifier)

U24DK066116 (U.S. NIH Grant/Contract)

IRB00011050 (Other Identifier)

U24DK137522 (U.S. NIH Grant/Contract)

DK66116

U01DK066174 (U.S. NIH Grant/Contract)

U01DK066143 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 Minnesota) 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).

Full description

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.

The goals have been extended to understand the impact of childhood CKD on: the risk factors for decline in kidney function in childhood and young adulthood; the development of cardiovascular disease in adolescence and young adulthood; the trajectories of markers of metabolic bone disease and the relationship to cardiovascular endpoints; and the social function, neurocognitive function and emotional well-being of adolescents and young adults and the relationship to successful transfer to adult nephrology care.

Enrollment: 1,300 estimated patients

Sex: All

Ages: 6 months to 22 years old

Volunteers: No Healthy Volunteers

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; age between 16 to 22 years (before 23rd birthday) for Cohort 4 and regularly seen by pediatric nephrologist prior to enrollment
• 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; an estimated GFR ≤60 based on the CKiD Under 25 estimating equation (U25eGFR) OR KRT experience (dialysis or transplant) for Cohort 4
• 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

• Solid organ (other than kidney), bone marrow or stem cell transplantation
• Cancer diagnosis and receiving treatment or within 12 months post completion of treatment
• HIV diagnosis and receiving treatment or within 12 months post completion of treatment
• Current pregnancy or pregnancy within past twelve months
• Inability to complete major data collection procedures
• 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 the family moves)
• Existing moderate to severe congenital structural heart disease
• Genetic syndromes involving the central nervous system (e.g., Downs syndrome)
• History of severe to profound intellectual disability (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

Trial design

1,300 participants in 4 patient groups

Cohort 1

Description:

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

Description:

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

Description:

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.

Cohort 4

Description:

Age between 16 and 22 years (before 23rd birthday) with moderately impaired kidney function as defined by estimated GFR less than 60 ml/min\|1.73m2 based on U25eGFR OR individuals who have initiated kidney replacement therapy (dialysis or transplant).