Chronic Kidney Disease in Children-Prospective Cohort Study (CKID)
Cohort 1 and Cohort 2 of an NIH sponsored study at 50 sites in North America of 280 children (up to 8 at Children[Single Quote]s Medical Center) between the ages of 1-16 years, with more mildly impaired kidney function, defined as an estimated GFR between 45 and 90 by the updated Schwartz Formula (eGFR).
Enrollment to Cohort 1 has been closed.
Amendment 5 opens enrollment to Cohort 2, All participants will receive all procedures they have consented for such as, consent, DNA consent, and telephone followup consent. This study will be comprise of approximately 140 children with glomerular disease and approximately 140 children with non-glomerular causes of disease.GFR measures the level of kidney function and determines the stage of kidney disease; it is calculated from the results of a blood creatinine test, age, race, gender and other factors. The study has been extended for 5 years (follow-up visits for up to four years in CKiD I and up to an additional five years in CKiD2, ending July 31, 2013.
The objective of annual follow-up visits will be to collect information on exposures; measure kidney disease progression; assess brain impairment, behavior and growth failure; determine health care utilization patterns assess the clinical events related to the primary outcomes since last contact.
The central laboratory will measure kidney function. A core laboratory will calibrate instruments for ambulatory blood pressure measurements and interpret and standardize methods for clinical blood pressure measurements. One center will read the psychological and behavior tests. The data repository is Research Triangle Institute, Research Triangle Park, NC.
Screening Procedures: Include physical examination, kidney function, blood, urine, and pregnancy testing, medical and surgical history, and demographic information (age, sex, ethnic origin).
Pre-Study: A Family Binder includes a study brochure, a study visit outline, scheduling information for the visits (dates, times, directions), and instructions on what to bring to the visit (birth and family history, medications list, education and household income, health care resources), a copy of the signed consent form and HIPAA form. A unique study number without any personal identifiers will be assigned.
Study Visits: There will be 9 study visits over 5-8 years-1 study visit per year except during the first year when there will be 2 study visits. For children over the age of 3, Study Visit 1B will be within 6 months after Study Visit 1A. For children 1 to 3 years of age, the second study visit will occur within 3 months of the first visit. Study visits 2 thru 8 will take place annually after Study Visit 1A.
Visit 1A Visit 1B Visit 2, 4, 6, 8 Visit 3,5, 7
Blood Collected 3-7 tsp 3-7 tsp 3-7 tsp 3-7 tsp
Time Allotment 7 hours 4 hours 7 hours 4 hours
Study Procedures: All study visits will take place at Children[Single Quote]s Medical Center Nephrology Clinic. At every visit, a brief physical examination and blood pressure determination will be preformed. Information about hospitalization (and the reason), medications including any investigational or study medications, herbal remedies, health supplements and/or vitamins, and over-the-counter drugs, dietary habits, sleep habits, physical activity, sexual activity and birth control methods used, and environmental exposures (such as smoking, drug, and alcohol use for teens) will be collected. A
* quality of life
* questionnaire to measure physical and emotional functioning will be done. A pregnancy test will be done at each visit when appropriate. Blood and urine tests will be done to measure kidney function at each study visit. If kidney function becomes worse, another visit within six months will be scheduled. An echocardiogram (ECHO) will be performed at Visits 2, 4, 6, and 8 , to study heart function.We will use this to find abnormalities of the heart.
Age between 1 and 16 years (before 17th birthday), fluent in English or Spanish
For Cohort 1, an Estimated (based on serum creatinine) GFR between 30 and 90 ml/min|1.73m2. For Cohort 2, an Estimated (based on serum creatinine) GFR between 45 and 90 ml/min|1.73m2.
Willingness and ability to provide informed consent and assent