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Trial record 1 of 2 for:    Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)
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Chronic Kidney Disease in Children Prospective Cohort Study (CKiD) (CKiD)

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ClinicalTrials.gov Identifier: NCT00327860
Recruitment Status : Recruiting
First Posted : May 19, 2006
Last Update Posted : August 9, 2018
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

Tracking Information
First Submitted Date May 18, 2006
First Posted Date May 19, 2006
Last Update Posted Date August 9, 2018
Study Start Date October 2003
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 7, 2018)
Time to Renal Replacement Therapy [ Time Frame: currently until the funding cycle ends in 2023 ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00327860 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 7, 2018)
Decline of Glomerular filtration rate (GFR) [ Time Frame: currently until the funding cycle ends in 2023 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)
Official Title Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)
Brief Summary 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).
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen 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. Whole blood samples will be collected at baseline and processed to create immortalized cell lines, and DNA samples. Genetic and biological specimens will be stored at the NIDDK Biosample Repository, which is Precision for Medicine in Frederick, MD.
Sampling Method Non-Probability Sample
Study Population 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.
Condition Chronic Kidney Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 7, 2018)
1081
Original Enrollment
 (submitted: May 18, 2006)
540
Estimated Study Completion Date July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months to 16 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Susan Furth, MD, PhD 215-590-2449 FurthS@email.chop.edu
Contact: Bradley Warady, MD 816-234-3812 bwarady@cmh.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00327860
Other Study ID Numbers 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Johns Hopkins Bloomberg School of Public Health
Study Sponsor Johns Hopkins Bloomberg School of Public Health
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)
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 Kansas City
Principal Investigator: George Schwartz, MD University of Rochester
Principal Investigator: Derek Ng, PhD Johns Hopkins Bloomberg School of Public Health
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date August 2018