Chronic Kidney Disease in Children Prospective Cohort Study (CKiD)

Обзор

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).

Подробное описание

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.

The goals have been extended to understand the impact of childhood CKD on: the risk factors for decline in kidney function in childhood and young adulthood; the development of cardiovascular disease in adolescence and young adulthood; the trajectories of markers of metabolic bone disease and the relationship to cardiovascular endpoints; and the social function, neurocognitive function and emotional well-being of adolescents and young adults and the relationship to successful transfer to adult nephrology care.

Первичные конечные точки

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

Вторичные конечные точки (2)

• Decline in Glomerular filtration rate (GFR) ml/min [Срок оценки: Up to 25 years]
• Decline in GFR and risk of cardiovascular disease progression [Срок оценки: Up to 25 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• Children's Mercy Kansas City — Kansas City
• The Children's Hospital of Philadelphia — Philadelphia

Публикации

• Woroniecki RP, Ng DK, Limou S, Winkler CA, Reidy KJ, Mitsnefes M, Sampson MG, Wong CS, Warady BA, Furth SL, Kopp JB, Kaskel FJ. Renal and Cardiovascular Morbidities Associated with APOL1 Status among African-American and Non-African-American Children with Focal Segmental Glomerulosclerosis. Front Pediatr. 2016 Nov 17;4:122. doi: 10.3389/fped.2016.00122. eCollection 2016. PMID 27900314
• Schwartz GJ, Wang H, Erway B, Nordin G, Seegmiller J, Lieske JC, Back SE, Miller WG, Eckfeldt JH. Multicenter Laboratory Comparison of Iohexol Measurement. J Appl Lab Med. 2018 Mar;2(5):711-724. doi: 10.1373/jalm.2017.024240. PMID 31276084
• Wong CS, Kogon AJ, Warady BA, Furth SL, Lantos JD, Wilfond BS. Ethical and Policy Considerations for Genomic Testing in Pediatric Research: The Path Toward Disclosing Individual Research Results. Am J Kidney Dis. 2019 Jun;73(6):837-845. doi: 10.1053/j.ajkd.2019.01.020. Epub 2019 Mar 14. PMID 30879919
• Schwartz GJ, Cox C, Seegmiller JC, Maier PS, DiManno D, Furth SL, Warady BA, Munoz A. Recalibration of cystatin C using standardized material in Siemens nephelometers. Pediatr Nephrol. 2020 Feb;35(2):279-285. doi: 10.1007/s00467-019-04389-2. Epub 2019 Nov 3. PMID 31680199
• Thomas E, Klomhaus AM, Laster ML, Furth SL, Warady BA, Salusky IB, Hanudel MR. Associations between anemia and FGF23 in the CKiD study. Pediatr Nephrol. 2024 Mar;39(3):837-847. doi: 10.1007/s00467-023-06160-0. Epub 2023 Sep 26. PMID 37752381
• Sandokji I, Xu Y, Denburg M, Furth S, Abraham AG, Greenberg JH. Current and Novel Biomarkers of Progression Risk in Children with Chronic Kidney Disease. Nephron. 2024;148(1):1-10. doi: 10.1159/000530918. Epub 2023 May 15. PMID 37232009
• Ren X, Chen J, Abraham AG, Xu Y, Siewe A, Warady BA, Kimmel PL, Vasan RS, Rhee EP, Furth SL, Coresh J, Denburg M, Rebholz CM; Chronic Kidney Disease Biomarkers Consortium. Plasma Metabolomics of Dietary Intake of Protein-Rich Foods and Kidney Disease Progression in Children. J Ren Nutr. 2024 Mar;34(2):95-104. doi: 10.1053/j.jrn.2023.10.007. Epub 2023 Nov 8. PMID 37944769
• Lee AM, Xu Y, Hu J, Xiao R, Hooper SR, Hartung EA, Coresh J, Rhee EP, Vasan RS, Kimmel PL, Warady BA, Furth SL, Denburg MR; CKD Biomarkers Consortium. Longitudinal Plasma Metabolome Patterns and Relation to Kidney Function and Proteinuria in Pediatric CKD. Clin J Am Soc Nephrol. 2024 Jul 1;19(7):837-850. doi: 10.2215/CJN.0000000000000463. Epub 2024 May 6. PMID 38709558

Идентификаторы

NCT: NCT00327860 · DK66116 · U01DK066143 · U01DK066174 · U24DK066116 · U24DK137522 · IRB10007880 · IRB00011050

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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