INSIGHT (Insight Into Nephrotic Syndrome)

Recruiting

• Conditions: Nephrotic Syndrome

• Registration Number: NCT01605266
• Lead Sponsor: The Hospital for Sick Children

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-05-22
• Study First Posted: 2012-05-24
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-25
• Primary Completion: 2032-01
• Study Completion: 2032-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

William Osler Health System, Brampton Civic Hospital and Peel Memorial Centre for Integrated Health and Wellness; 🇨🇦 Brampton, Ontario, Canada

Hamilton Health Sciences Corporation - McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada

Rouge Valley Health System, Rouge Valley Centenary; 🇨🇦 Scarborough, Ontario, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada