An observational study in Nephrotic Syndrome in Children, Nephrotic Syndrome, Minimal Change and Nephrotic Syndrome，Idiopathic, sponsored by University of Calgary. Status unknown at 12 sites in Canada. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2019-05-06.
Sponsored by University of Calgary · Observational
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.
192 studies on the registry are indexed under Nephrotic Syndrome; 63 are open to participants now.
This study's planned enrollment of 400 is above the median of 136 across 60 observational studies indexed under Nephrotic Syndrome.
Browse Nephrotic Syndrome studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
Time frame: 30 months up to 90 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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University of Calgary