INSIGHT (Insight Into Nephrotic Syndrome)

Официальное название

INSIGHT (Insight Into Nephrotic Syndrome: Investigating Genes, Health and Therapeutics)

Обзор

INSIGHT is a longitudinal study of childhood nephrotic syndrome to determine genetic, serologic and environmental factors contributing to nephrotic syndrome and disease progression.

Подробное описание

INSIGHT is a longitudinal observational study of childhood nephrotic syndrome to determine genetic, serologic and environmental factors contributing to nephrotic syndrome and disease progression. This is a large multiethnic cohort to test hypotheses of gene and environmental risk factors and disease progression. Participants are recruited from Toronto, Ontario and surrounding regions. Additional sites will be added on in the future.

Первичные конечные точки

• Relapse (number of relapses) [Срок оценки: Entire follow-up]

Вторичные конечные точки (5)

• Frequently relapsing NS (yes or no) [Срок оценки: 6, 12, 18 and 24 months]
• Steroid - dependent NS (yes or no) [Срок оценки: 6, 12, 18 and 24 months]
• Initial Steroid Resistance (yes or no) [Срок оценки: Up to 16 weeks]
• CKD (yes or no) [Срок оценки: Entire follow-up]
• ESRD (yes or no) [Срок оценки: Entire follow-up]

Критерии участия

Критерии включения

• diagnosis of nephrotic syndrome
• signed informed consent and assent appropriate for age
• ages 6 months -18 years old and
• ability to complete questionnaires

Критерии исключения

• congenital nephrotic syndrome (less than age 1)
• syndromic disease with multiple organ involvement
• inability to provide consent by primary care providers
• conditions such as systemic lupus erythematous.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 4 центра

• William Osler Health System, Brampton Civic Hospital and Peel Memorial Centre for Integrat — Brampton
• Hamilton Health Sciences Corporation - McMaster University Medical Centre — Hamilton
• Rouge Valley Health System, Rouge Valley Centenary — Scarborough Village
• The Hospital for Sick Children — Toronto

Публикации

• Hussain N, Zello JA, Vasilevska-Ristovska J, Banh TM, Patel VP, Patel P, Battiston CD, Hebert D, Licht CP, Piscione TD, Parekh RS. The rationale and design of Insight into Nephrotic Syndrome: Investigating Genes, Health and Therapeutics (INSIGHT): a prospective cohort study of childhood nephrotic syndrome. BMC Nephrol. 2013 Jan 26;14:25. doi: 10.1186/1471-2369-14-25. PMID 23351121
• Borges K, Vasilevska-Ristovska J, Hussain-Shamsy N, Patel V, Banh T, Hebert D, Pearl RJ, Radhakrishnan S, Piscione TD, Licht CP, Langlois V, Levin L, Strug L, Parekh RS. Parental attitudes to genetic testing differ by ethnicity and immigration in childhood nephrotic syndrome: a cross-sectional study. Can J Kidney Health Dis. 2016 Mar 17;3:16. doi: 10.1186/s40697-016-0104-y. eCollection 2016. PMID 26998310
• Banh THM, Hussain-Shamsy N, Patel V, Vasilevska-Ristovska J, Borges K, Sibbald C, Lipszyc D, Brooke J, Geary D, Langlois V, Reddon M, Pearl R, Levin L, Piekut M, Licht CPB, Radhakrishnan S, Aitken-Menezes K, Harvey E, Hebert D, Piscione TD, Parekh RS. Ethnic Differences in Incidence and Outcomes of Childhood Nephrotic Syndrome. Clin J Am Soc Nephrol. 2016 Oct 7;11(10):1760-1768. doi: 10.2215/CJN.0 PMID 27445165
• Borges K, Sibbald C, Hussain-Shamsy N, Vasilevska-Ristovska J, Banh T, Patel V, Brooke J, Piekut M, Reddon M, Aitken-Menezes K, McNaughton A, Pearl RJ, Langlois V, Radhakrishnan S, Licht CPB, Piscione TD, Levin L, Noone D, Hebert D, Parekh RS. Parental Health Literacy and Outcomes of Childhood Nephrotic Syndrome. Pediatrics. 2017 Mar;139(3):e20161961. doi: 10.1542/peds.2016-1961. Epub 2017 Feb 17. PMID 28213606
• Konstantelos N, Banh T, Patel V, Vasilevska-Ristovska J, Borges K, Hussain-Shamsy N, Noone D, Hebert D, Radhakrishnan S, Licht CPB, Langlois V, Pearl RJ, Parekh RS. Association of low birth weight and prematurity with clinical outcomes of childhood nephrotic syndrome: a prospective cohort study. Pediatr Nephrol. 2019 Sep;34(9):1599-1605. doi: 10.1007/s00467-019-04255-1. Epub 2019 Apr 11. PMID 30976899
• Riar SS, Banh THM, Borges K, Subbarao P, Patel V, Vasilevska-Ristovska J, Chanchlani R, Hussain-Shamsy N, Noone D, Hebert D, Licht CPB, Langlois V, Pearl RJ, Parekh RS. Prevalence of Asthma and Allergies and Risk of Relapse in Childhood Nephrotic Syndrome: Insight into Nephrotic Syndrome Cohort. J Pediatr. 2019 May;208:251-257.e1. doi: 10.1016/j.jpeds.2018.12.048. Epub 2019 Feb 4. PMID 30732999
• Robinson CH, Aman N, Banh THM, Brooke J, Dhillon V, Garner M, Licht C, McKay A, Pearl R, Radhakrishnan S, Rasool K, Selvathesan N, Teoh CW, Vasilevska-Ristovska J, Parekh RS. Challenging Clinical Practice Guideline Definitions in Childhood Nephrotic Syndrome. Clin J Am Soc Nephrol. 2025 Dec 1;20(12):1767-1779. doi: 10.2215/CJN.0000000842. Epub 2025 Oct 15. PMID 41091558
• Robinson C, Wagner S, Aman N, Banh THM, Dhillon V, Langlois V, Licht C, McKay A, Noone D, Pearl R, Radhakrishnan S, Teoh CW, Vasilevska-Ristovska J, Parekh RS. Incidence and Risk Factors for Hypertension among Children with Nephrotic Syndrome. J Pediatr. 2025 Sep;284:114443. doi: 10.1016/j.jpeds.2024.114443. Epub 2024 Dec 20. PMID 39710174

Идентификаторы

NCT: NCT01605266 · 1000021384

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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