Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)
ConditionChronic Kidney Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-22
SponsorJohns Hopkins Bloomberg School of Public Health
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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.
Disqualifiers
Solid organ (other than kidney), bone marrow or stem cell transplantation
Cancer diagnosis and receiving treatment or within 12 months post completion of treatment
Ongoing monitoring for cardiotoxic effects of prior chemotherapy or targeted cancer therapies (e.g., anthracyclines, trastuzumab)
HIV infection with detectable viral load despite current antiretroviral therapy
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,300 Participants
are grouped into 4 trial groupsGroup A: Cohort 1
Group B: Cohort 2
Group C: Cohort 3
Group D: Cohort 4
Trial outcomes
Primary outcomes
1
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.
Time frame
Annually up to 5 yearsSecondary outcomes
1
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.
Time frame
Up to 25 years2
Decline in GFR and risk of cardiovascular disease progression
Analyze the association between decline in GFR and risk of progression of cardiovascular disease at regular annual study visits.
Time frame
Up to 25 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins Bloomberg School of Public Health
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov