Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT00327860
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; age between 16 to 22 years (before 23rd birthday) for Cohort 4 and regularly seen by pediatric nephrologist prior to enrollment
* 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; an estimated GFR ≤60 based on the CKiD Under 25 estimating equation (U25eGFR) OR KRT experience (dialysis or transplant) for Cohort 4
* 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:
* Solid organ (other than kidney), bone marrow or stem cell transplantation
* Cancer diagnosis and receiving treatment or within 12 months post completion of treatment
* HIV diagnosis and receiving treatment or within 12 months post completion of treatment
* Current pregnancy or pregnancy within past twelve months
* Inability to complete major data collection procedures
* 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 the family moves)
* Existing moderate to severe congenital structural heart disease
* Genetic syndromes involving the central nervous system (e.g., Downs syndrome)
* History of severe to profound intellectual disability (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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
22 Years
Study:
NCT00327860
Study Brief:
Protocol Section:
NCT00327860