Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)

This study is currently recruiting participants.
Verified May 2011 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00327860
First received: May 18, 2006
Last updated: November 18, 2013
Last verified: May 2011

May 18, 2006
November 18, 2013
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 GFR [ Time Frame: currently until the funding cycle ends in 2018 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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 National Institute of Neurological Disorders and Stroke (NINDS), the 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 and a Data Coordinating Center to conduct a prospective epidemiological study of children with chronic kidney disease (CKD). 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.

Not Provided
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. Two clinical coordinating centers at Children's Mercy Hospital in Kansas and at Children's Hospital of Philadelphia in Philadelphia, PA (previously at the Johns Hopkins Medical Institutions in Baltimore, MD), a central laboratory at the University of Rochester, and a data coordinating center at Johns Hopkins School of Public Health have formed a cooperative agreement to conduct a prospective study of chronic kidney disease in children. 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; growth failure and its associated morbidity; and neurocognitive function and behavior.

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.
 
Recruiting
830
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/leukemia 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., IQ<40, significant impairment in adaptive function and/or inability to independently execute self-care skills)
Both
1 Year to 16 Years
No
Contact: Susan Furth, MD, PhD 215-590-2449 FurthS@email.chop.edu
Contact: Bradley Warady, MD 816-234-3812 bwarady@cmh.edu
United States
 
NCT00327860
DK66116, U01-DK-66143, U01-DK-66174, U01DK066116, U01-DK-82194
Yes
Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • 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
May 2011

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