CHILDNEPH The Canadian Childhood Nephrotic Syndrome Study (CHILDNEPH)

May 2, 2019 updated by: University of Calgary

The Canadian Childhood Nephrotic Syndrome (CHILDNEPH) Project

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Recruiting
        • Alberta Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Susan Samuel, MD MSc
        • Sub-Investigator:
          • Silviu Grisaru, MD
        • Sub-Investigator:
          • Andrew Wade, MD PhD
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • Stollery Children's Hospital, University of Alberta
        • Contact:
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Recruiting
        • British Columbia Children's Hospital
        • Contact:
        • Contact:
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1S1
        • Recruiting
        • Winnipeg Children's Hospital, University of Manitoba
        • Contact:
        • Contact:
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Recruiting
        • IWK Health Centre
        • Contact:
          • James Tee, MD
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Children's Hospital, London Health Sciences Centre
        • Contact:
      • Ottawa, Ontario, Canada, K1H 8L1
        • Recruiting
        • Children's Hospital of Eastern Ontario (CHEO) University of Ottawa
        • Contact:
        • Contact:
      • Toronto, Ontario, Canada, M5G 1X8
    • Quebec
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Recruiting
        • Royal University Hospital, University of Saskatchewan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children (ages 1 to 17 years) who are diagnosed with Nephrotic Syndrome (minimal change disease or idiopathic NS) who present at a participating pediatric nephrology clinic in Canada.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Prospective Treatments for NS

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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of steroid dose prescribed with relapse rates
Time Frame: 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.
30 months up to 90 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2014

Primary Completion (Anticipated)

June 30, 2020

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

June 6, 2018

First Submitted That Met QC Criteria

December 19, 2018

First Posted (Actual)

December 26, 2018

Study Record Updates

Last Update Posted (Actual)

May 6, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB13-0059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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