Nephrotic Syndrome in ChildrenCHILDNEPHNCT03786263
CHILDNEPH The Canadian Childhood Nephrotic Syndrome Study
An observational study of Nephrotic Syndrome in Children and Nephrotic Syndrome, Minimal Change, run by University of Calgary at 12 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Nephrotic Syndrome in Children, Nephrotic Syndrome, Minimal Change, Nephrotic Syndrome，Idiopathic
- How many people
- 400 participants
- Where
- 12 sitesCanada
- Study dates
- 3 Aug 2014to 31 Mar 2022
- How long will I take part?
- 30 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Diagnosis with Nephrotic Sydrome at initial presentation, first or second relapse
Who cannot join
- unable to participate in English or French
- Nephrotic Syndrome is secondary to other disease
- Younger than one year old or older than 17 years
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Canada12 sites, 12 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Laurel Ryan, MFA, 403-955-7160, laurel.ryan@ahs.ca
Maneka Perinpanayagam, PhD, 403-955-2467, maneka.perinpanayagam@ahs.ca
- Recruiting
Stollery Children's Hospital, University of Alberta
Edmonton, Alberta, T6G 2B7
Catherine Morgan, MD, cmorgan@ualberta.ca
- Recruiting
IWK Health Centre
Halifax, Nova Scotia, B3H 1V7
James Tee, MD
- Recruiting
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
Steve Arora, MD, arorast@mcmaster.ca
Rahul Chanchlani, MD, chanchlr@mcmaster.ca
- Recruiting
Children's Hospital, London Health Sciences Centre
London, Ontario, N6A 5W9
Guido Filler, MD, guido.filler@lhsc.on.ca
- Recruiting
CHU Ste. Justine
Montreal, Quebec, B3H 1V7
Genevieve Benoit, MD, 514-345-4931 ext. 7729, genevieve.benoit.hsj@ssss.gouv.qc.ca
Anne-Laure Lapeyraque, MD, 514-345-4931 ext. 7729, anne-laure.lapeyraque.hsj@ssss.gouv.qc.ca
- Recruiting
Montreal Children's Hospital - McGill University
Montreal, Quebec, H4A 3J1
Beth Foster, MD, beth.foster@muhc.mcgill.ca
- Recruiting
Children's Hospital of Eastern Ontario (CHEO) University of Ottawa
Ottawa, Ontario, K1H 8L1
Pavel Geier, MD, pgeier@cheo.on.ca
Janusz Feber, MD, jfeber@cheo.on.ca
- Recruiting
Royal University Hospital, University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
Robin Erickson, MD, robin.erickson@usask.ca
- Recruiting
The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G 1X8
Rulan Parekh, MD, rulan.parekh@sickkids.ca
- Recruiting
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Cherry Mammen, MD, 604-875-2345 ext. 7254, cmammen@cw.bc.ca
Allison Eddy, MD, 604-875-2345 ext. 7254, allison.eddy@cw.bc.ca
- Recruiting
Winnipeg Children's Hospital, University of Manitoba
Winnipeg, Manitoba, R3A 1S1
Allison Dart, MD, adart@hsc.mb.ca
Maury Pinsk, MD, mpinsk@hsc.mb.ca
About this study
Official title: The Canadian Childhood Nephrotic Syndrome (CHILDNEPH) Project
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.
Read the 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.
- Conditions
- Nephrotic Syndrome in Children, Nephrotic Syndrome, Minimal Change, Nephrotic Syndrome，Idiopathic
- Medical subject headings
- Nephrosis, Lipoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 months up to 90 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start3 Aug 2014
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic Syndrome in ChildrenStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 30 Months
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Samuel, MD, MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786263
- Sponsor's protocol ID
- REB13-0059
- Acronym
- CHILDNEPH
- Status last verified
- May 2019
- First submitted
- 6 Jun 2018
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Canadian Childhood Nephrotic Syndrome (CHILDNEPH) Project
- ClinicalTrials.gov ID
- NCT03786263
- Acronym / sponsor ID
- CHILDNEPH / REB13-0059
- Conditions
- Nephrotic Syndrome in Children, Nephrotic Syndrome, Minimal Change, Nephrotic Syndrome，Idiopathic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 3 Aug 2014 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Diagnosis with Nephrotic Sydrome at initial presentation, first or second relapse
Key exclusion criteria (3 listed)
- unable to participate in English or French
- Nephrotic Syndrome is secondary to other disease
- Younger than one year old or older than 17 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Samuel, MD, MSc principal investigator
University of Calgary
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrotic Syndrome in Children and Nephrotic Syndrome, Minimal Change, run by University of Calgary at 12 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurel Ryan, MFA (403-955-7160, laurel.ryan@ahs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of steroid dose prescribed with relapse rates (time frame: 30 months up to 90 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.