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Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)
This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), June 2008
Sponsors and Collaborators: 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)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00327860
  Purpose

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.


Condition
Chronic Kidney Disease

U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Biospecimen Retention:   Samples With DNA

Biospecimen 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.


Estimated Enrollment: 540
Study Start Date: October 2003
Estimated Study Completion Date: July 2008
  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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 Johns Hopkins School of Medicine, 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.

Criteria

Inclusion Criteria:

  • Age between 1 and 16 years (before 17th birthday)
  • Estimated (based on SCr) GFR between 30 and 75 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327860

Contacts
Contact: Susan Furth, MD, PhD 410-502-7964 sfurth@jhmi.edu
Contact: Bradley Warady, MD 816-234-3812 bwarady@cmh.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Susan Furth, MD, PhD     410-502-7964     sfurth@jhmi.edu    
Contact: Jacqueline Ndirangu, MPH     410-563-6222 ext 230     jndiran1@jhmi.edu    
Principal Investigator: Susan Furth, MD, PhD            
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Bradley Warady, MD     816-234-3812     bwarady@cmh.edu    
Contact: Julie Starr, RN, MSN, CNN, CCRP     816-855-1744     jwstarr@cmh.edu    
Principal Investigator: Bradley Warady, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Alvaro Muñoz, PhD Johns Hopkins University
Principal Investigator: Susan Furth, MD, PhD Johns Hopkins University
Principal Investigator: Bradley Warady, MD Children's Mercy Hospital
  More Information

CKiD Website  This link exits the ClinicalTrials.gov site

Publications of Results:
Other Publications:
Responsible Party: Johns Hopkins Bloomberg School of Public Health ( Dr. Alvaro Muñoz )
Study ID Numbers: DK66116, U01-DK-66143, U01-DK-66174, U01-DK-66116
Study First Received: May 18, 2006
Last Updated: June 6, 2008
ClinicalTrials.gov Identifier: NCT00327860  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 14, 2009