INSIGHT (Insight Into Nephrotic Syndrome)

Overview

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

Full Title of Study: “INSIGHT (Insight Into Nephrotic Syndrome: Investigating Genes, Health and Therapeutics)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2032

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.

Arms, Groups and Cohorts

  • Nephrotic Syndrome
    • The cohort includes all children diagnosed with nephrotic syndrome between ages 1-18. Children and their caregiver must be willing to provide informed consent, complete questionnaires, and provide biospecimens of the child. Those with secondary causes of nephrotic syndrome and/or systemic disease are excluded.

Clinical Trial Outcome Measures

Primary Measures

  • Relapse (number of relapses)
    • Time Frame: Entire follow-up
    • After remission, an increase in the first AM morning urine protein ≥ 3+ for 3 consecutive days or increase in maintenance prednisone dose

Secondary Measures

  • Frequently relapsing NS (yes or no)
    • Time Frame: 6, 12, 18 and 24 months
    • 4 or more relapses within any 12 month interval OR 2 or more relapses within the first 6 months since diagnosis
  • Steroid – dependent NS (yes or no)
    • Time Frame: 6, 12, 18 and 24 months
    • 2 relapses during steroid taper or a relapse within 14 days of steroid discontinuation
  • Initial Steroid Resistance (yes or no)
    • Time Frame: Up to 16 weeks
    • Commencing second line medication due to no response from prednisone with initial treatment
  • CKD (yes or no)
    • Time Frame: Entire follow-up
    • eGFR less than or equal to 60mg/ml/1.73m^2 for 3 or more consecutive months
  • ESRD (yes or no)
    • Time Frame: Entire follow-up
    • eGFR less than or equal to 15 mg/ml/1.73m^2, or initiation of dialysis or receiving a transplant.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Hospital for Sick Children
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rulan Parekh, Staff Physician – The Hospital for Sick Children
  • Overall Official(s)
    • Rulan Parekh, MD, Principal Investigator, The Hospital for Sick Children
  • Overall Contact(s)
    • Rulan Parekh, MD, 416-813-7654, rulan.parekh@sickkids.ca

References

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.

Citations Reporting on Results

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.

Banh TH, 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 CP, 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.

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.

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.

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.

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