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INSIGHT (Insight Into Nephrotic Syndrome)

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01605266
Acronym
INSIGHT
Enrollment
1000
Registered
2012-05-24
Start date
2011-01-31
Completion date
2032-01-31
Last updated
2022-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrotic Syndrome

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

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Relapse (number of relapses)Entire follow-upAfter remission, an increase in the first AM morning urine protein ≥ 3+ for 3 consecutive days or increase in maintenance prednisone dose

Secondary

MeasureTime frameDescription
Frequently relapsing NS (yes or no)6, 12, 18 and 24 months4 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 months2 relapses during steroid taper or a relapse within 14 days of steroid discontinuation
Initial Steroid Resistance (yes or no)Up to 16 weeksCommencing second line medication due to no response from prednisone with initial treatment
CKD (yes or no)Entire follow-upeGFR less than or equal to 60mg/ml/1.73m\^2 for 3 or more consecutive months
ESRD (yes or no)Entire follow-upeGFR less than or equal to 15 mg/ml/1.73m\^2, or initiation of dialysis or receiving a transplant.

Countries

Canada

Contacts

Primary ContactRulan Parekh, MD
rulan.parekh@sickkids.ca416-813-7654

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026