INSIGHT (Insight Into Nephrotic Syndrome)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nephrotic Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of nephrotic syndrome signed informed consent and assent appropriate for age ages 6 months -18 years old and ability to complete questionnaires Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nephrotic Syndrome<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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. | Entire follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, kidney disease, minimal change disease, focal segmental glomerulosclerosis, nephrotic syndrome