NCT01605266

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
66mo left

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jan 2011Jan 2032

Study Start

First participant enrolled

January 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 24, 2012

Completed
19.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2032

Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

21 years

First QC Date

April 20, 2012

Last Update Submit

October 24, 2022

Conditions

Nephrotic Syndrome

Keywords

pediatrickidney diseaseminimal change diseasefocal segmental glomerulosclerosisnephrotic syndrome

Outcome Measures

Primary Outcomes (1)

  • Relapse (number of relapses)

    After remission, an increase in the first AM morning urine protein ≥ 3+ for 3 consecutive days or increase in maintenance prednisone dose

    Entire follow-up

Secondary Outcomes (5)

  • Frequently relapsing NS (yes or no)

    6, 12, 18 and 24 months

  • Steroid - dependent NS (yes or no)

    6, 12, 18 and 24 months

  • Initial Steroid Resistance (yes or no)

    Up to 16 weeks

  • CKD (yes or no)

    Entire follow-up

  • ESRD (yes or no)

    Entire follow-up

Study Arms (1)

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.

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with nephrotic syndrome. Children are recruited from Toronto and surrounding region with additional sites added later.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

William Osler Health System, Brampton Civic Hospital and Peel Memorial Centre for Integrated Health and Wellness

Brampton, Ontario, L6R 3J7, Canada

RECRUITING

Hamilton Health Sciences Corporation - McMaster University Medical Centre

Hamilton, Ontario, L8L 8E7, Canada

RECRUITING

Rouge Valley Health System, Rouge Valley Centenary

Scarborough Village, Ontario, M1E 4B9, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Related Publications (7)

  • 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: 23351121BACKGROUND

  • 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: 26998310RESULT

  • 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.

    PMID: 27445165RESULT

  • 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: 28213606RESULT

  • 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: 30976899RESULT

  • 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: 30732999RESULT

  • 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: 41091558DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood is drawn for DNA, serum, plasma, buffy coat and whole blood. Urine and toenail clippings are also collected.

MeSH Terms

Conditions

Nephrotic SyndromeKidney DiseasesNephrosis, LipoidGlomerulosclerosis, Focal Segmental

Condition Hierarchy (Ancestors)

NephrosisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGlomerulonephritisNephritis

Study Officials

  • Rulan Parekh, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rulan Parekh, MD

CONTACT

416-813-7654rulan.parekh@sickkids.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

April 20, 2012

First Posted

May 24, 2012

Study Start

January 1, 2011

Primary Completion (Estimated)

January 1, 2032

Study Completion (Estimated)

January 1, 2032

Last Updated

October 25, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(4)