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Chronic Kidney Disease in Children Prospective Cohort Study (CKiD) (CKiD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00327860
First received: May 18, 2006
Last updated: May 10, 2016
Last verified: February 2016

May 18, 2006
May 10, 2016
October 2003
July 2018   (final data collection date for primary outcome measure)
Time to Renal Replacement Therapy [ Time Frame: currently until the funding cycle ends in 2018 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00327860 on ClinicalTrials.gov Archive Site
Decline of Glomerular filtration rate (GFR) [ Time Frame: currently until the funding cycle ends in 2018 ] [ Designated as safety issue: No ]
Not Provided
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Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)
Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)
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 Rochester) 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).
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood and urine specimens will be collected at the baseline visit and at each annual follow-up visit. Nail clippings and hair samples will be collected at baseline.Specimens will be stored at the NIDDK Biosample Repository, which is Fisher BioServices Corporation in Rockville, MD.

The genetics repository will receive blood samples and process them to create immortalized cell lines, and DNA samples. Whole blood for the genetic repository will be collected at baseline. The genetics repository is at Rutgers, the State University of New Jersey in New Brunswick, NJ.

Non-Probability Sample
The CKiD Study is a multi-center, prospective cohort study of children aged 1 to 16 years with mild to moderate impaired kidney function. The study population consist of two cohorts.
Chronic Kidney Disease
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
891
July 2018
July 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 1 and 16 years (before 17th birthday)
  • Estimated (based on SCr) GFR between 30 and 90 ml/min|1.73m2
  • Willingness and ability to provide informed consent and assent

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 (e.g., allergic reaction to iodine or Iohexol)
  • 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., intelligence quotient (IQ)<40, significant impairment in adaptive function and/or inability to independently execute self-care skills)
Both
1 Year to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00327860
DK66116, U01DK066143, U01DK066174, U01DK066116, U01DK082194
Yes
Not Provided
Not Provided
Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Alvaro Muñoz, PhD Johns Hopkins Bloomberg School of Public Health
Principal Investigator: Susan Furth, MD, PhD Children's Hospital of Philadelphia
Principal Investigator: Bradley Warady, MD Children's Mercy Hospital
Principal Investigator: George Schwartz, MD University of Rochester
Johns Hopkins Bloomberg School of Public Health
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP