CHILDNEPH The Canadian Childhood Nephrotic Syndrome Study

NCT ID: NCT03786263

Last Updated: 2019-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-03

Study Completion Date

2022-03-31

Brief Summary

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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

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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.

Conditions

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Nephrotic Syndrome in Children Nephrotic Syndrome, Minimal Change Nephrotic Syndrome,Idiopathic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Samuel, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status RECRUITING

Stollery Children's Hospital, University of Alberta

Edmonton, Alberta, Canada

Site Status RECRUITING

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Winnipeg Children's Hospital, University of Manitoba

Winnipeg, Manitoba, Canada

Site Status RECRUITING

IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status RECRUITING

McMaster Children's Hospital

Hamilton, Ontario, Canada

Site Status RECRUITING

Children's Hospital, London Health Sciences Centre

London, Ontario, Canada

Site Status RECRUITING

Children's Hospital of Eastern Ontario (CHEO) University of Ottawa

Ottawa, Ontario, Canada

Site Status RECRUITING

The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada

Site Status RECRUITING

CHU Ste. Justine

Montreal, Quebec, Canada

Site Status RECRUITING

Montreal Children's Hospital - McGill University

Montreal, Quebec, Canada

Site Status RECRUITING

Royal University Hospital, University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Laurel Ryan, MFA

Role: CONTACT

403-955-7160

Maneka Perinpanayagam, PhD

Role: CONTACT

403-955-2467

Facility Contacts

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Laurel Ryan, MFA

Role: primary

403-955-7160

Maneka Perinpanayagam, PhD

Role: backup

403-955-2467

Catherine Morgan, MD

Role: primary

Cherry Mammen, MD

Role: primary

604-875-2345 ext. 7254

Allison Eddy, MD

Role: backup

604-875-2345 ext. 7254

Allison Dart, MD

Role: primary

Maury Pinsk, MD

Role: backup

James Tee, MD

Role: primary

Steve Arora, MD

Role: primary

Rahul Chanchlani, MD

Role: backup

Guido Filler, MD

Role: primary

Pavel Geier, MD

Role: primary

Janusz Feber, MD

Role: backup

Rulan Parekh, MD

Role: primary

Genevieve Benoit, MD

Role: primary

514-345-4931 ext. 7729

Anne-Laure Lapeyraque, MD

Role: backup

514-345-4931 ext. 7729

Beth Foster, MD

Role: primary

Robin Erickson, MD

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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REB13-0059

Identifier Type: -

Identifier Source: org_study_id

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