Clinical trial NCT00826319: Canadian Study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular Events Over Time
Official title: CanPREDDICT: Canadian Study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular Events Over Time
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Renal Insufficiency
Biomarkers
Observational
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 2602
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nephrology Clinics across Canada

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Renal Replacement Therapy
timeFrame: 6 monthly for 3 years, annually up to 5 years
measure: Cardiovascular events
timeFrame: 6 monthly for 3 years, annually up to 5 years
measure: Death
timeFrame: 6 monthly for 3 years, annually up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Penticton
country: Canada
facility: Penticton Regional Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: St John's
country: Canada
facility: Eastern Regional Health Authority, Health Sciences Centre
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Sydney
country: Canada
facility: Cape Breton District Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: St Joseph's Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Science Centre- University Campus
state: Ontario
city: London
country: Canada
facility: London Health Science Centre- Victoria Campus
state: Ontario
city: Oak Ridges
country: Canada
facility: York Central
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
city: Timmins
country: Canada
facility: Timmins & District Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Greenfield Park
country: Canada
facility: Charles Le Moyne Hospital
state: Quebec
city: Montreal
country: Canada
facility: Hôpital du Sacré-Coeur
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Montréal
country: Canada
facility: Maisonneuve-Rosemont Hopital
state: Quebec
city: Quebec City
country: Canada
facility: CHUQ: L'Hôtel-Dieu de Québec
state: Quebec
Study officials:
affiliation: University of British Columbia
name: Adeera Levin
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.