Brief Summary
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).
Brief Title
Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)
Detailed 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.
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.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
215-590-2449
Central Contact Email
FurthS@email.chop.edu
Central Contact Role
Contact
Central Contact Phone
816-302-3010
Central Contact Email
bwarady@cmh.edu
Completion Date
Completion Date Type
Estimated
Conditions
Chronic Kidney Disease
Eligibility Criteria
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
* 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
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
22 Years
Minimum Age
6 Months
NCT Id
NCT00327860
Org Class
Other
Org Full Name
Johns Hopkins Bloomberg School of Public Health
Org Study Id
DK66116
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)
Primary Outcomes
Outcome Description
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.
Outcome Measure
Time to Kidney Replacement Therapy
Outcome Time Frame
Annually up to 5 years
Secondary Ids
Secondary Id
U01DK066143
Secondary Id
U01DK066174
Secondary Id
U24DK066116
Secondary Id
U24DK137522
Secondary Id
IRB10007880
Secondary Id
IRB00011050
Secondary Outcomes
Outcome Description
Define and identify novel and traditional risk factors for the accelerated decline of GFR at regular annual study visits.
Outcome Time Frame
Up to 25 years
Outcome Measure
Decline in Glomerular filtration rate (GFR) ml/min
Outcome Description
Analyze the association between decline in GFR and risk of progression of cardiovascular disease at regular annual study visits.
Outcome Time Frame
Up to 25 years
Outcome Measure
Decline in GFR and risk of cardiovascular disease progression
See Also Links
Url
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
The CKiD Study is a multi-center, prospective cohort study of children, adolescents and young adults with a history of mild to moderate impaired kidney function. The study population consist of four cohorts.
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
22
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Frederick Kaskel
Investigator Email
FKASKEL@montefiore.org
Investigator Phone
718-655-1120