CHILDNEPH The Canadian Childhood Nephrotic Syndrome Study

Nephrotic Syndrome in Children Clinical Trial

— CHILDNEPH  

Official title:

The Canadian Childhood Nephrotic Syndrome (CHILDNEPH) Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03786263
• Other study ID #: REB13-0059
• Status: Recruiting
• Start date: August 3, 2014
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2019
• Source: University of Calgary
• Contact: Laurel Ryan, MFA
• Phone: 403-955-7160
• Email: laurel.ryan[@]ahs.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 31, 2022
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Nephrosis
• Nephrosis, Lipoid
• Nephrotic Syndrome
• Nephrotic Syndrome in Children
• Nephrotic Syndrome, Minimal Change
• Nephrotic Syndrome,Idiopathic
• Syndrome

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Stollery Children's Hospital, University of Alberta	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	Children's Hospital, London Health Sciences Centre	London	Ontario
Canada	CHU Ste. Justine	Montréal	Quebec
Canada	Montreal Children's Hospital - McGill University	Montréal	Quebec
Canada	Children's Hospital of Eastern Ontario (CHEO) University of Ottawa	Ottawa	Ontario
Canada	Royal University Hospital, University of Saskatchewan	Saskatoon	Saskatchewan
Canada	The Hospital for Sick Children (SickKids)	Toronto	Ontario
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
Canada	Winnipeg Children's Hospital, University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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