Chronic Kidney Disease in Children Study (CKiD)

M
Marciana Laster

Primary Investigator

Enrolling By Invitation
6 months - 17 years
All
Phase N/A
1 participants needed
3 Locations

Brief description of study

What is the purpose of this study?
The primary goals of this study are to determine the risk factors for decline in kidney function and to define how a progressive decline in kidney function impacts neurocognitive function and behavior; the risk factors for cardiovascular disease; and growth failure and its associated morbidity.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY -  Eligible participants identified via recruitment sources and strategies available at their particular site. These include: automated laboratory database searches for eligible patients age 6 months to 16 years with reduced kidney function, referrals from physicians or specialty centers of potential participants, or other methods.

Detailed description of study

What will happen during the study?
The design of the CKiD study is a prospective, observational cohort of children with chronic kidney disease. Exposures will be measured at baseline and scheduled annual follow-up visits will permit the subsequent updating of the exposures in cohort participants. Outcomes will also be assessed at the annual visits and they include: measures of kidney function; neurocognitive function; markers of risk factors for cardiovascular disease; growth and other co-morbid conditions. The study will use the power of the cohort design with regularly scheduled visits at which markers of disease progression will be measured under standardized procedures. Levels and longitudinal changes in markers will constitute the primary outcomes. The study will collect data on clinical events with primary interest in ESRD and death. Such events will provide time-to-event data to determine heterogeneity of times to ESRD in children with mild to moderate chronic kidney disease. 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic kidney disease, CKD, Riley
  • Age: 6 months - 17 years
  • Gender: All

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 2, 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. 

Exclusion Criteria
Among the children who fulfill the inclusion criteria, certain medical conditions and/or the inability to assess exposures of interest will deem them ineligible. Specifically, the following conditions comprise the 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., 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 kidney replacement therapy within 6 months of date of enrollment will not be recruited.

Updated on 28 Apr 2025. Study ID: PNEPH-JHOPKINS-CKID, 1011002901, 17114
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