CHILDNEPH The Canadian Childhood Nephrotic Syndrome Study

• Conditions: Nephrotic Syndrome, Minimal Change; Nephrotic Syndrome in Children; Nephrotic Syndrome，Idiopathic

• Registration Number: NCT03786263
• Lead Sponsor: University of Calgary

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-08-03
• Study First Submitted: 2018-06-06
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-26
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-06
• Primary Completion: 2020-06-30
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Diagnosis with Nephrotic Sydrome at initial presentation, first or second relapse

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association of steroid dose prescribed with relapse rates	30 months up to 90 months	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.

Trial Locations

Locations (12)

British Columbia Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Stollery Children's Hospital, University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada

Royal University Hospital, University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada

CHU Ste. Justine; 🇨🇦 Montréal, Quebec, Canada

Winnipeg Children's Hospital, University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

Montreal Children's Hospital - McGill University; 🇨🇦 Montréal, Quebec, Canada

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada

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

McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada

Children's Hospital of Eastern Ontario (CHEO) University of Ottawa; 🇨🇦 Ottawa, Ontario, Canada

Children's Hospital, London Health Sciences Centre; 🇨🇦 London, Ontario, Canada