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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurel Ryan, MFA | Contact | 403-955-7160 | laurel.ryan@ahs.ca | |
| Maneka Perinpanayagam, PhD | Contact | 403-955-2467 | maneka.perinpanayagam@ahs.ca |
| Name | Affiliation | Role |
|---|---|---|
| Susan Samuel, MD, MSc | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital | Recruiting | Calgary | Alberta | T3B 6A8 | Canada |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 25, 2015 | Aug 10, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009402 | Nephrosis, Lipoid |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Stollery Children's Hospital, University of Alberta | Recruiting | Edmonton | Alberta | T6G 2B7 | Canada |
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| British Columbia Children's Hospital | Recruiting | Vancouver | British Columbia | V6H 3V4 | Canada |
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| Winnipeg Children's Hospital, University of Manitoba | Recruiting | Winnipeg | Manitoba | R3A 1S1 | Canada |
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| IWK Health Centre | Recruiting | Halifax | Nova Scotia | B3H 1V7 | Canada |
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| McMaster Children's Hospital | Recruiting | Hamilton | Ontario | L8N 3Z5 | Canada |
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| Children's Hospital, London Health Sciences Centre | Recruiting | London | Ontario | N6A 5W9 | Canada |
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| Children's Hospital of Eastern Ontario (CHEO) University of Ottawa | Recruiting | Ottawa | Ontario | K1H 8L1 | Canada |
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| The Hospital for Sick Children (SickKids) | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
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| CHU Ste. Justine | Recruiting | Montreal | Quebec | B3H 1V7 | Canada |
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| Montreal Children's Hospital - McGill University | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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| Royal University Hospital, University of Saskatchewan | Recruiting | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |