{"id":1221,"date":"2020-04-21T13:55:10","date_gmt":"2020-04-21T13:55:10","guid":{"rendered":"https:\/\/statepi.jhsph.edu\/ckid_wp\/?page_id=1221"},"modified":"2025-01-17T17:17:07","modified_gmt":"2025-01-17T22:17:07","slug":"study-design","status":"publish","type":"page","link":"https:\/\/statepi.jhsph.edu\/ckid\/study-design\/","title":{"rendered":"Study Design"},"content":{"rendered":"

Study Design<\/strong><\/h3>\n

CKiD is a prospective, observational cohort of children, adolescents, and young adults with chronic kidney disease. The exposures and outcome of interest are measured at a participant’s first study visit, and then continually collected at annual follow-up visits, allowing investigators to understand how CKD and the health of this population change over time.<\/p>\n

There are many outcomes of interest measured at CKiD yearly follow-up visits. A few of them include measures of kidney function such as GFR and urine protein to creatinine ratio, neurocognitive function, markers of risk factors for cardiovascular disease, growth, and other co-morbid conditions. CKiD leverages the power of the cohort study design through these regularly scheduled visits where markers of disease progression can be measured in a standardized setting. CKiD also collects data on important clinical events that are particularly meaningful to this population, specifically the onset of end-stage kidney disease (ESKD) and death.<\/p>\n

CKiD also follows participants after transplant and initiation of dialysis (kidney replacement therapy (KRT)). Collecting data on participants in this phase allows investigators to understand the determinants of long-term positive outcomes post-KRT.<\/p>\n

For a full description and schedule of CKiD study visits, please see the schematics below.<\/p>\n<\/div><\/section>\n

Study Population<\/strong><\/h3>\n

The CKiD Study enrolls children and adolescents with mild-to-moderate CKD of both glomerular and non-glomerular disease etiology. CKiD has been enrolled in 3 waves: Cohort 1, Cohort 2, Cohort 3, and currently enrolling Cohort 4.<\/p>\n

Cohort 1 enrolled approximately 600 racially and ethnically diverse children between the ages of 1 and 16 with GFRs between 30 and 90 ml\/min|1.73m2<\/sup>. Cohort 2 enrolled approximately 300 children with slightly more mild CKD compared to those in Cohort 1, as the GFR requirement was between 45 and 90 ml\/min|1.73m2<\/sup>. Cohort 3 enrolled roughly 200 participants between the ages of 6 months and 16 years with a non-glomerular CKD diagnosis within 5 years of being enrolled. Finally, Cohort 4, the most recent cohort, is enrolling participants 16 to 22 years old with moderately impaired kidney function defined as GFR <60ml\/min|1.73m2<\/sup>, and those who have initiated kidney replacement therapy (dialysis or transplantation).<\/p>\n

Please see below for specific details on the inclusion and exclusion criteria of the CKiD Study.<\/p>\n<\/div><\/section>\n

<\/span><\/span><\/div>\n

Inclusion & Exclusion Criteria<\/strong><\/h3>\n<\/div><\/section>\n
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General Inclusion Criteria<\/strong><\/p>\n

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  • 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<\/sup> birthday) for Cohort 4 and regularly seen by pediatric nephrologist prior to enrollment<\/li>\n
  • Estimated (based on SCr) Schwartz GFR between 30 and 90 ml\/min|1.73m2<\/sup>\u00a0for Cohort 1 OR an estimated GFR between 45 and 90 ml\/min|1.73m2<\/sup>\u00a0based on the updated Schwartz formula for Cohort 2; an estimated GFR \u226460 based on the CKiD Under 25 estimating equation (U25eGFR) OR KRT experience (dialysis or transplant) for Cohort 4<\/li>\n
  • Willingness and ability to provide informed consent and assent<\/li>\n
  • 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<\/li>\n
  • For Cohort 3, 190 children with non-glomerular diagnosis and duration of kidney disease less than 5 years were enrolled<\/li>\n
  • For Cohort 4, 100 adolescents and young adults (AYA) with moderately impaired kidney function defined as U25eGFR <60ml\/min|1.73m2 <\/sup>(KRT-na\u00efve) and 100 AYAs who have initiated kidney replacement therapy (KRT experience) will be enrolled<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/section>\n

    The following conditions comprise the exclusion criteria for Cohort 4:<\/p>\n

      \n
    • Solid organ (other than kidney), bone marrow or stem cell transplantation<\/li>\n
    • Cancer diagnosis and receiving treatment or within 12 months post completion of treatment<\/li>\n
    • HIV diagnosis\/treatment and receiving treatment or within 12 months post completion of treatment<\/li>\n
    • Current pregnancy or pregnancy within past twelve months<\/li>\n
    • Inability to complete major data collection procedures<\/li>\n
    • Not fluent in English or Spanish<\/li>\n
    • Plans to move out of area of any participating CKiD site (Families can be transferred to another CKiD site if they move)<\/li>\n
    • Existing moderate to severe congenital structural heart disease<\/li>\n
    • Genetic syndromes involving the central nervous system (e.g., Down syndrome)<\/li>\n
    • History of Severe to Profound Intellectual Disability (i.e., IQ < 40, significant impairment in adaptive functioning and\/or inability to independently execute self-care skills)<\/li>\n
    • For cohorts 3, children who were expected to receive kidney replacement therapy within 6 months of date of enrollment were not recruited<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/section>\n<\/div>\n
      <\/span><\/span><\/div>\n\n