Nephrotic Syndrome
Conditions
Keywords
pediatric, kidney disease, minimal change disease, focal segmental glomerulosclerosis, nephrotic syndrome
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.
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.
Interventions
None listed
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse (number of relapses) | 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
| Measure | Time frame | Description |
|---|---|---|
| Frequently relapsing NS (yes or no) | 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) | 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) | Up to 16 weeks | Commencing second line medication due to no response from prednisone with initial treatment |
| CKD (yes or no) | Entire follow-up | eGFR less than or equal to 60mg/ml/1.73m\^2 for 3 or more consecutive months |
| ESRD (yes or no) | Entire follow-up | eGFR less than or equal to 15 mg/ml/1.73m\^2, or initiation of dialysis or receiving a transplant. |
Countries
Canada