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CHILDNEPH The Canadian Childhood Nephrotic Syndrome Study (CHILDNEPH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03786263
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Calgary

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.

Condition or disease
Nephrotic Syndrome in Children Nephrotic Syndrome, Minimal Change Nephrotic Syndrome,Idiopathic

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Months
Official Title: The Canadian Childhood Nephrotic Syndrome (CHILDNEPH) Project
Actual Study Start Date : August 3, 2014
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786263


Contacts
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Contact: Laurel Ryan, MFA 403-955-7160 laurel.ryan@ahs.ca
Contact: Maneka Perinpanayagam, PhD 403-955-2467 maneka.perinpanayagam@ahs.ca

Locations
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Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Laurel Ryan, MFA    403-955-7160    laurel.ryan@ahs.ca   
Contact: Maneka Perinpanayagam, PhD    403-955-2467    maneka.perinpanayagam@ahs.ca   
Principal Investigator: Susan Samuel, MD MSc         
Sub-Investigator: Silviu Grisaru, MD         
Sub-Investigator: Andrew Wade, MD PhD         
Stollery Children's Hospital, University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Catherine Morgan, MD       cmorgan@ualberta.ca   
Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Cherry Mammen, MD    604-875-2345 ext 7254    cmammen@cw.bc.ca   
Contact: Allison Eddy, MD    604-875-2345 ext 7254    allison.eddy@cw.bc.ca   
Canada, Manitoba
Winnipeg Children's Hospital, University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3A 1S1
Contact: Allison Dart, MD       adart@hsc.mb.ca   
Contact: Maury Pinsk, MD       mpinsk@hsc.mb.ca   
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: James Tee, MD         
Canada, Ontario
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Steve Arora, MD       arorast@mcmaster.ca   
Contact: Rahul Chanchlani, MD       chanchlr@mcmaster.ca   
Children's Hospital, London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Guido Filler, MD       guido.filler@lhsc.on.ca   
Children's Hospital of Eastern Ontario (CHEO) University of Ottawa Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Pavel Geier, MD       pgeier@cheo.on.ca   
Contact: Janusz Feber, MD       jfeber@cheo.on.ca   
The Hospital for Sick Children (SickKids) Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Rulan Parekh, MD       rulan.parekh@sickkids.ca   
Canada, Quebec
CHU Ste. Justine Recruiting
Montréal, Quebec, Canada, B3H 1V7
Contact: Genevieve Benoit, MD    514-345-4931 ext 7729    genevieve.benoit.hsj@ssss.gouv.qc.ca   
Contact: Anne-Laure Lapeyraque, MD    514-345-4931 ext 7729    anne-laure.lapeyraque.hsj@ssss.gouv.qc.ca   
Montreal Children's Hospital - McGill University Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Beth Foster, MD       beth.foster@muhc.mcgill.ca   
Canada, Saskatchewan
Royal University Hospital, University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Robin Erickson, MD       robin.erickson@usask.ca   
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Susan Samuel, MD, MSc University of Calgary
  Study Documents (Full-Text)

Documents provided by University of Calgary:
Study Protocol  [PDF] February 25, 2015


Additional Information:

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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03786263     History of Changes
Other Study ID Numbers: REB13-0059
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Nephrotic Syndrome
Nephrosis
Nephrosis, Lipoid
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases