Canadian Study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular Events Over Time
- Conditions
- Chronic Kidney Disease
- Registration Number
- NCT00826319
- Lead Sponsor
- University of British Columbia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2602
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Renal Replacement Therapy 6 monthly for 3 years, annually up to 5 years Renal Replacement Therapy is defined as dialysis start or transplantation.
Cardiovascular events 6 monthly for 3 years, annually up to 5 years 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.
Death 6 monthly for 3 years, annually up to 5 years 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Foothills Hospital
🇨🇦Calgary, Alberta, Canada
Penticton Regional Hospital
🇨🇦Penticton, British Columbia, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Cape Breton District Health Authority
🇨🇦Sydney, Nova Scotia, Canada
St. Boniface Hospital
🇨🇦Winnipeg, Manitoba, Canada
Eastern Regional Health Authority, Health Sciences Centre
🇨🇦St John's, Newfoundland and Labrador, Canada
QEII Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
St Joseph's Hospital
🇨🇦Hamilton, Ontario, Canada
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
London Health Science Centre- University Campus
🇨🇦London, Ontario, Canada
London Health Science Centre- Victoria Campus
🇨🇦London, Ontario, Canada
York Central
🇨🇦Oak Ridges, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
University of Ottawa
🇨🇦Ottawa, Ontario, Canada
Timmins & District Hospital
🇨🇦Timmins, Ontario, Canada
Charles Le Moyne Hospital
🇨🇦Greenfield Park, Quebec, Canada
Sunnybrook Hospital
🇨🇦Toronto, Ontario, Canada
University Health Network
🇨🇦Toronto, Ontario, Canada
Hôpital du Sacré-Coeur
🇨🇦Montreal, Quebec, Canada
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
Maisonneuve-Rosemont Hopital
🇨🇦Montréal, Quebec, Canada
CHUQ: L'Hôtel-Dieu de Québec
🇨🇦Quebec City, Quebec, Canada
BC Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada