Health TrialsbyHealthPanel

INSIGHT (Insight Into Nephrotic Syndrome)

ConditionNephrotic Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorThe Hospital for Sick Children

About this trial

INSIGHT is a longitudinal study of childhood nephrotic syndrome to determine genetic, serologic and environmental factors contributing to nephrotic syndrome and disease progression.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosis of nephrotic syndrome

signed informed consent and assent appropriate for age

ages 6 months -18 years old and

ability to complete questionnaires

Disqualifiers

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.

Trial population

Children with nephrotic syndrome. Children are recruited from Toronto and surrounding region with additional sites added later.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Nephrotic Syndrome

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hospital for Sick Children

Lead sponsor

Source ClinicalTrials.gov
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