CHILDNEPH The Canadian Childhood Nephrotic Syndrome Study
CHILDNEPH
The Canadian Childhood Nephrotic Syndrome (CHILDNEPH) Project
1 other identifier
observational
400
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2014
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 3, 2014
CompletedFirst Submitted
Initial submission to the registry
June 6, 2018
CompletedFirst Posted
Study publicly available on registry
December 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedMay 6, 2019
May 1, 2019
5.9 years
June 6, 2018
May 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- Diagnosis with Nephrotic Sydrome at initial presentation, first or second relapse
You may not qualify if:
- unable to participate in English or French
- Nephrotic Syndrome is secondary to other disease
- Younger than one year old or older than 17 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
Stollery Children's Hospital, University of Alberta
Edmonton, Alberta, T6G 2B7, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
Winnipeg Children's Hospital, University of Manitoba
Winnipeg, Manitoba, R3A 1S1, Canada
IWK Health Centre
Halifax, Nova Scotia, B3H 1V7, Canada
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5, Canada
Children's Hospital, London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Children's Hospital of Eastern Ontario (CHEO) University of Ottawa
Ottawa, Ontario, K1H 8L1, Canada
The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G 1X8, Canada
CHU Ste. Justine
Montreal, Quebec, B3H 1V7, Canada
Montreal Children's Hospital - McGill University
Montreal, Quebec, H4A 3J1, Canada
Royal University Hospital, University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Samuel, MD, MSc
University of Calgary
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 30 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2018
First Posted
December 26, 2018
Study Start
August 3, 2014
Primary Completion
June 30, 2020
Study Completion
March 31, 2022
Last Updated
May 6, 2019
Record last verified: 2019-05