Recruiting

Observational Study

Sponsor:

Johns Hopkins Bloomberg School of Public Health

Code:

NCT00327860

Conditions

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 0 - 22

Healthy Volunteers: Not accepted

Study Details

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 Minnesota) 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).

Conditions

Chronic Kidney Disease

Study ID

NCT00327860

Start date

Oct, 2003

Status verified date

Apr, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 22

Healthy Volunteers: Not accepted

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
  • 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
  • Ongoing monitoring for cardiotoxic effects of prior chemotherapy or targeted cancer therapies (e.g., anthracyclines, trastuzumab)
  • HIV infection with detectable viral load despite current antiretroviral therapy
  • 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

Study Design

Enrollment

1300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Cohort 4

Age between 16 and 22 years (before 23rd birthday) with moderately impaired kidney function as defined by estimated GFR less than 60 ml/min\|1.73m2 based on U25eGFR OR individuals who have initiated kidney replacement therapy (dialysis or transplant).

Primary outcome measure

  • Time to Kidney Replacement Therapy [ Time Frame: Annually up to 5 years ]

Central Contacts and Locations

Central contacts

Susan Furth, MD, PhD

215-590-2449FurthS@email.chop.edu

Bradley Warady, MD

816-302-3010bwarady@cmh.edu

Locations

Children's Mercy Kansas City

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Bradley Warady, MD

816-302-3010bwarady@cmh.edu

Christine Smith, BSN, RN, CCRC

816-302-3278casmith@cmh.edu

Principal Investigator:

Bradley Warady, MD

The Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19146

Contacts

Susan Furth, MD, PhD

215-590-2449FurthS@email.chop.edu

Hannah Derwick, MPH

267-425-1394DERWICKH@chop.edu

Principal Investigator:

Susan Furth, MD, PhD

More Information

Sponsor

Johns Hopkins Bloomberg School of Public Health

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health on 2026-04-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.