An observational study in Nephrotic Syndrome, sponsored by The Hospital for Sick Children. Recruiting at 4 sites in Canada. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2022-10-25.
Sponsored by The Hospital for Sick Children · Observational
INSIGHT is a longitudinal study of childhood nephrotic syndrome to determine genetic, serologic and environmental factors contributing to nephrotic syndrome and disease progression.
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.
191 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 125 across 59 observational studies indexed under Nephrotic Syndrome.
Browse Nephrotic Syndrome studies →The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children with nephrotic syndrome. Children are recruited from Toronto and surrounding region with additional sites added later.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Time frame: Entire follow-up
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
Time frame: 6, 12, 18 and 24 months
Steroid - dependent NS (yes or no)
2 relapses during steroid taper or a relapse within 14 days of steroid discontinuation
Time frame: 6, 12, 18 and 24 months
Initial Steroid Resistance (yes or no)
Commencing second line medication due to no response from prednisone with initial treatment
Time frame: Up to 16 weeks
CKD (yes or no)
eGFR less than or equal to 60mg/ml/1.73m\^2 for 3 or more consecutive months
Time frame: Entire follow-up
ESRD (yes or no)
eGFR less than or equal to 15 mg/ml/1.73m\^2, or initiation of dialysis or receiving a transplant.
Time frame: Entire follow-up
Plan to share: No
The record gives a start of Jan 2011, a primary completion of Jan 2032 and a completion of Jan 2032. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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