Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)

This study is currently recruiting participants. (see Contacts and Locations)
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
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Time to Renal Replacement Therapy [ Time Frame: currently until the funding cycle ends in 2018 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decline of GFR [ Time Frame: currently until the funding cycle ends in 2018 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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: 830
Study Start Date: October 2003
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
  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 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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327860

Contacts
Contact: Susan Furth, MD, PhD 215-590-2449 FurthS@email.chop.edu
Contact: Bradley Warady, MD 816-234-3812 bwarady@cmh.edu

Locations
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         
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Susan Furth, MD, PhD    215-590-2449    FurthS@email.chop.edu   
Contact: Jacqueline Ndirangu, MPH    267-426-8388    NdiranguJ@email.chop.edu   
Principal Investigator: Susan Furth, MD, PhD         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
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
  More Information

Additional Information:
Publications:

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00327860     History of Changes
Other Study ID Numbers: DK66116, U01-DK-66143, U01-DK-66174, U01DK066116, U01-DK-82194
Study First Received: May 18, 2006
Last Updated: November 18, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 28, 2014