Clinical trial NCT03786263: CHILDNEPH The Canadian Childhood Nephrotic Syndrome Study
Official title: The Canadian Childhood Nephrotic Syndrome (CHILDNEPH) Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nephrotic Syndrome in Children
Nephrotic Syndrome, Minimal Change
Nephrotic Syndrome，Idiopathic
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Association of steroid dose prescribed with relapse rates
timeFrame: 30 months up to 90 months
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital, University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Children's Hospital, University of Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: London
country: Canada
facility: Children's Hospital, London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario (CHEO) University of Ottawa
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children (SickKids)
state: Ontario
city: Montréal
country: Canada
facility: CHU Ste. Justine
state: Quebec
city: Montréal
country: Canada
facility: Montreal Children's Hospital - McGill University
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital, University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Calgary
name: Susan Samuel, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: