Clinical trial NCT01605266: INSIGHT (Insight Into Nephrotic Syndrome)
Official title: INSIGHT (Insight Into Nephrotic Syndrome: Investigating Genes, Health and Therapeutics)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nephrotic Syndrome
Keywords: pediatric
kidney disease
minimal change disease
focal segmental glomerulosclerosis
nephrotic syndrome
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2012-05-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with nephrotic syndrome. Children are recruited from Toronto and surrounding region with additional sites added later.

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. diagnosis of nephrotic syndrome
2. signed informed consent and assent appropriate for age
3. ages 6 months -18 years old and
4. ability to complete questionnaires

Exclusion Criteria:

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

Primary outcomes:
measure: Relapse (number of relapses)
timeFrame: Entire follow-up
Secondary outcomes:
measure: Frequently relapsing NS (yes or no)
timeFrame: 6, 12, 18 and 24 months
measure: Steroid - dependent NS (yes or no)
timeFrame: 6, 12, 18 and 24 months
measure: Initial Steroid Resistance (yes or no)
timeFrame: Up to 16 weeks
measure: CKD (yes or no)
timeFrame: Entire follow-up
measure: ESRD (yes or no)
timeFrame: Entire follow-up
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: William Osler Health System, Brampton Civic Hospital and Peel Memorial Centre for Integrated Health and Wellness
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation - McMaster University Medical Centre
state: Ontario
city: Scarborough
country: Canada
facility: Rouge Valley Health System, Rouge Valley Centenary
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Rulan Parekh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.00380116. Epub 2016 Jul 21.
citation: 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.
citation: 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.
citation: 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.