Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)
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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) |
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 2013 |
Eligibility| Ages Eligible for Study: | 1 Year to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
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| Contact: Susan Furth, MD, PhD | 215-590-2449 | FurthS@email.chop.edu |
| Contact: Bradley Warady, MD | 816-234-3812 | bwarady@cmh.edu |
| 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 | |
| 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: | April 5, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 19, 2013