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Nephrotic SyndromeINSIGHTNCT01605266

INSIGHT (Insight Into Nephrotic Syndrome)

An observational study of Nephrotic Syndrome, run by The Hospital for Sick Children at 4 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 6 months to 18 years
Conditions the study is for
Nephrotic Syndrome
How many people
1,000 participants
Where
4 sitesCanada
Study dates
Jan 2011to Jan 2032
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rulan Parekh, MD contact

416-813-7654 ext. 306459

rulan.parekh@sickkids.ca

Canada4 sites, 4 recruiting

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

    Brampton, Ontario, L6R 3J7

    Rachel J Pearl, MD

    Rulan Parekh, MD

    Recruiting

  • Hamilton Health Sciences Corporation - McMaster University Medical Centre

    Hamilton, Ontario, L8L 8E7

    Rahul Chanchlani, MD

    Rahul Chanchlani, MD, MSc

    Recruiting

  • Rouge Valley Health System, Rouge Valley Centenary

    Scarborough Village, Ontario, M1E 4B9

    Hubert Wong, MD

    Rulan Parekh, MD

    Recruiting

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

    Rulan Parekh, MD

    Diane Hebert, MD

    Recruiting

Other trials in Canada

About this study

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

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

Read the 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.

Keywords
pediatric, kidney disease, minimal change disease, focal segmental glomerulosclerosis, nephrotic syndrome
Medical subject headings
Nephrotic Syndrome, Kidney Diseases, Nephrosis, Lipoid, Glomerulosclerosis, Focal Segmental

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01605266
Study groupRoleWhat they receive
Nephrotic SyndromeThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Entire follow-up

Secondary outcomes (5)

  1. Frequently relapsing NS (yes or no)

    4 or more relapses within any 12 month interval OR 2 or more relapses within the first 6 months since diagnosis

    Measured: 6, 12, 18 and 24 months

  2. Steroid - dependent NS (yes or no)

    2 relapses during steroid taper or a relapse within 14 days of steroid discontinuation

    Measured: 6, 12, 18 and 24 months

  3. Initial Steroid Resistance (yes or no)

    Commencing second line medication due to no response from prednisone with initial treatment

    Measured: Up to 16 weeks

  4. CKD (yes or no)

    eGFR less than or equal to 60mg/ml/1.73m^2 for 3 or more consecutive months

    Measured: Entire follow-up

  5. ESRD (yes or no)

    eGFR less than or equal to 15 mg/ml/1.73m^2, or initiation of dialysis or receiving a transplant.

    Measured: Entire follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2012 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2032 (estimated)
  4. Study completionJan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01605266
Sponsor's protocol ID
1000021384
Acronym
INSIGHT
Status last verified
Oct 2022
First submitted
20 Apr 2012
Last updated
25 Oct 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.00380116. Epub 2016 Jul 21.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 39710174

Questions about this trial

What is this clinical trial studying?

An observational study of Nephrotic Syndrome, run by The Hospital for Sick Children at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rulan Parekh, MD (416-813-7654 ext. 306459, rulan.parekh@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse (number of relapses) (time frame: Entire follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01605266, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.

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