INSIGHT (Insight Into Nephrotic Syndrome)

The Hospital for Sick Children1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Nephrotic Syndrome

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

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

Brampton, Ontario, Canada

RECRUITING

Hamilton Health Sciences Corporation - McMaster University Medical Centre

Hamilton, Ontario, Canada

RECRUITING

Rouge Valley Health System, Rouge Valley Centenary

Scarborough Village, Ontario, Canada

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Rulan Parekh, MD

CONTACT

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

Data from ClinicalTrials.gov

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