CHILDNEPH The Canadian Childhood Nephrotic Syndrome Study

Study Overview
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Brief Summary
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CHILDNEPH is a pan-Canadian project to observe clinical care for children with nephrotic syndrome. Previous studies have indicated that there is wide practice variation in how health care providers treat this remitting and relapsing disease of childhood. The disease mechanism is not yet understood, and long-term use of steroids can affect children's health. This study involves assessment of routine clinical care and establishing a long-term patient registry for children with nephrotic syndrome.

Detailed Description
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CHILDNEPH is an ongoing prospective longitudinal study of children with incident and prevalent nephrotic syndrome. Children are recruited from 12 centres across Canada and followed for at least 30 months. The project starting in August of 2013 with the goal of following 400 patients. Data is collected at enrollment, beginning and end of each relapse, semi-annual visits and end of study. Detailed prescription data is collected regarding glucocorticoids and all second line agents. All relapses are recorded with time to urinary remission of proteinuria. The investigators are moving towards registry based trials to determine optimal treatment protocols for nephrotic syndrome with an overall goal to minimize glucocorticoid exposure, a patient priority.

Official Title
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The Canadian Childhood Nephrotic Syndrome (CHILDNEPH) Project

Conditions
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Nephrotic Syndrome in Children, Nephrotic Syndrome, Minimal Change, Nephrotic Syndrome，Idiopathic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis with Nephrotic Sydrome at initial presentation, first or second relapse Exclusion Criteria: unable to participate in English or French Nephrotic Syndrome is secondary to other disease Younger than one year old or older than 17 years

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective Treatments for NS<br>Observation of children (between the ages of 1 and 17) who are diagnosed with Nephrotic Syndrome at their initial presentation, first or second relapse. Observation of children who receive Glucocorticoids to treat Nephrotic Syndrome. Observation of children who receive other drugs (Second Line Agents) for Nephrotic Syndrome. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of steroid dose prescribed with relapse rates | Total steroid dose prescribed per unit time is determined by the total dose patients are prescribed during observation divided by total number of days on treatment. Dose will always be in mg/m2 prednisone equivalents. The relapse rate is the number of relapses/per person unit time. | 30 months up to 90 months |