We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified August 2017 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT00327860
First Posted: May 19, 2006
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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
May 18, 2006
May 19, 2006
August 22, 2017
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 ]
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 ]
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 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 6 months to 16 years with mild to moderate impaired kidney function. The study population consist of three cohorts.
Chronic Kidney Disease
Not Provided
  • Cohort 1
    Age between 1 and 16 years (before 17th birthday) and estimated (based on SCr) Schwartz GFR between 30 and 90 ml/min|1.73m2
  • Cohort 2
    Age between 1 and 16 years (before 17th birthday), estimated GFR between 45 and 90 ml/min|1.73m2 based on the updated Schwartz formula, and an equal distribution of children with glomerular and non-glomerular causes of disease were enrolled (i.e., 150 within each) and the study placed an upper limit of 60% for the percent of enrolled with non-glomerular disease.
  • Cohort 3
    Age between 6 months and 16 years (before 17th birthday) with non-glomerular diagnosis and duration of kidney disease less than 5 years will be enrolled.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1196
July 2018
July 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • 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
  • 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.

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
  • 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)
  • For cohort 3, children who are expected to receive renal replacement therapy within 6 months of date of enrollment will not be recruited
Sexes Eligible for Study: All
6 Months to 16 Years   (Child)
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
U01DK066143 ( U.S. NIH Grant/Contract )
U01DK066174 ( U.S. NIH Grant/Contract )
U01DK066116 ( U.S. NIH Grant/Contract )
U01DK082194 ( U.S. NIH Grant/Contract )
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 Kansas City
Principal Investigator: George Schwartz, MD University of Rochester
Johns Hopkins Bloomberg School of Public Health
August 2017