- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00826319
Canadian Study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular Events Over Time (CanPREDDICT)
November 27, 2013 updated by: University of British Columbia
CanPREDDICT: Canadian Study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular Events Over Time
This study will follow 2500 prevalent Chronic Kidney Disease (CKD) patients with Glomerular Filtration Rate (GFR) from 15-45 ml/min for 30 months with serial measurements every 6 months and subsequent annual chart review up to 60 months.
This observational study will analyze the demographics, clinical status, medications and blood and urine samples of these patients and study the conventional biochemical, hormonal and metabolic parameters assessing which underlying biomarkers reflect the processes involved with disease progression.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Actual)
2602
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada
- Foothills Hospital
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Edmonton, Alberta, Canada
- University of Alberta
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British Columbia
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Penticton, British Columbia, Canada
- Penticton Regional Hospital
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Vancouver, British Columbia, Canada
- Vancouver General Hospital
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Vancouver, British Columbia, Canada
- BC Children's Hospital
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Vancouver, British Columbia, Canada
- St. Paul's Hospital
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Manitoba
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Winnipeg, Manitoba, Canada
- St. Boniface Hospital
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Newfoundland and Labrador
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St John's, Newfoundland and Labrador, Canada
- Eastern Regional Health Authority, Health Sciences Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada
- QEII Health Sciences Centre
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Sydney, Nova Scotia, Canada
- Cape Breton District Health Authority
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Ontario
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Hamilton, Ontario, Canada
- St Joseph's Hospital
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Kingston, Ontario, Canada
- Kingston General Hospital
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London, Ontario, Canada
- London Health Science Centre- Victoria Campus
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London, Ontario, Canada
- London Health Science Centre- University Campus
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Oak Ridges, Ontario, Canada
- York Central
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Ottawa, Ontario, Canada
- University of Ottawa
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Timmins, Ontario, Canada
- Timmins & District Hospital
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Toronto, Ontario, Canada
- St. Michael's Hospital
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Toronto, Ontario, Canada
- University Health Network
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Toronto, Ontario, Canada
- Sunnybrook Hospital
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Quebec
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Greenfield Park, Quebec, Canada
- Charles Le Moyne Hospital
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Montreal, Quebec, Canada
- Royal Victoria Hospital
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Montreal, Quebec, Canada
- Hopital du Sacre-Coeur
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Montréal, Quebec, Canada
- Maisonneuve-Rosemont Hopital
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Quebec City, Quebec, Canada
- CHUQ: L'Hôtel-Dieu de Québec
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Nephrology Clinics across Canada
Description
Inclusion Criteria:
- Patients currently seen by a nephrologist, or referred for evaluation of CKD
- GFR between 15-45 ml/min
- Adults 19 years (depending on age of consent in province) or older
- At pediatric sites study participants will be eligible to participate at age 15 or older
Exclusion Criteria:
- Organ transplant recipient
- Life expectancy less than 12 months
- Acute Vasculitis
- Bioimpedance sub-study exclusion criteria:
- Amputation (readings are inaccurate)
- Any battery operated or electronic implanted device (such as pacemaker or implanted defibrillator - potential electrical hazard)
- Pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Bioimpedance sub-study cohort
Funded by a grant from Kidney Foundation of Canada, Dr. Catherine Clase initiated a bioimpedance sub-study across 7 centres and recruited n=416 within the CANPREDDICT population.
The study uses bioimpedance measurements to assess volume status to determine the multivariable relationship between baseline volume overload and subsequent cardiovascular events.
Subjects are followed at 6 months intervals for 2 years.
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Ethnic enrichment cohort
Additional recruitment initiated and funded by the Principal Investigator, Adeera Levin for enriching the ethnic representation within the Canadian cohort on South Asian and Oriental Asian was completed from Sept 2012 to June 2013, n=53.
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Original CanPreddict cohort
The original CanPreddict cohort was recruited from Jun 2008 - Oct 2009 has 2544 CKD patients across Canada.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Renal Replacement Therapy
Time Frame: 6 monthly for 3 years, annually up to 5 years
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Renal Replacement Therapy is defined as dialysis start or transplantation.
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6 monthly for 3 years, annually up to 5 years
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Cardiovascular events
Time Frame: 6 monthly for 3 years, annually up to 5 years
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Cardiovascular events are defined as myocardial infarction, ischemic and hemorrhagic stroke, coronary revascularization, congestive heart failure, peripheral bypass and gangrenes, adjudicated by a nephrologist, cardiologist and neurologist.
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6 monthly for 3 years, annually up to 5 years
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Death
Time Frame: 6 monthly for 3 years, annually up to 5 years
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Deaths are reported with source documentation and adjudicated for ischemic or congestive cardiovascular death, other cardiovascular death, non-cardiovascular death and unknown cause of death.
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6 monthly for 3 years, annually up to 5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adeera Levin, University of British Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Levin A, Rigatto C, Brendan B, Madore F, Muirhead N, Holmes D, Clase CM, Tang M, Djurdjev O; CanPREDDICT investigators. Cohort profile: Canadian study of prediction of death, dialysis and interim cardiovascular events (CanPREDDICT). BMC Nephrol. 2013 Jun 11;14:121. doi: 10.1186/1471-2369-14-121.
- Levin A, Rigatto C, Barrett B, Madore F, Muirhead N, Holmes D, Clase C, Tang M, Djurdjev O. (2012). Canadian study of prediciont of death, dialysis and interim cardiovascular events: CanPREDDICT: Biomarkers improve prediction of one year outcomes in chronic kidney disease cohort. Clinical studies in CKD. Nephrology Dialysis Transplantation, 27(suppl 2), ii63-ii65.
- Levin A, Rigatto C, Barrett B, Madore F, Muirhead N, Holmes D, Clase CM, Tang M, Djurdjev O; CanPREDDICT Investigators. Biomarkers of inflammation, fibrosis, cardiac stretch and injury predict death but not renal replacement therapy at 1 year in a Canadian chronic kidney disease cohort. Nephrol Dial Transplant. 2014 May;29(5):1037-47. doi: 10.1093/ndt/gft479. Epub 2013 Dec 26.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
January 20, 2009
First Submitted That Met QC Criteria
January 21, 2009
First Posted (Estimate)
January 22, 2009
Study Record Updates
Last Update Posted (Estimate)
November 28, 2013
Last Update Submitted That Met QC Criteria
November 27, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H07-02457
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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