Canadian Study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular Events Over Time (CanPREDDICT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00826319
First received: January 20, 2009
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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.


Condition
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CanPREDDICT: Canadian Study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular Events Over Time

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Renal Replacement Therapy [ Time Frame: 6 monthly for 3 years, annually up to 5 years ] [ Designated as safety issue: No ]
    Renal Replacement Therapy is defined as dialysis start or transplantation.

  • Cardiovascular events [ Time Frame: 6 monthly for 3 years, annually up to 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 monthly for 3 years, annually up to 5 years ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Serum,Plasma,Urine, DNA and RNA


Enrollment: 2602
Study Start Date: June 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
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.
Original CanPreddict cohort
The original CanPreddict cohort was recruited from Jun 2008 - Oct 2009 has 2544 CKD patients across Canada.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Nephrology Clinics across Canada

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826319

Locations
Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
Penticton Regional Hospital
Penticton, British Columbia, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Canada, Manitoba
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Canada, Newfoundland and Labrador
Eastern Regional Health Authority, Health Sciences Centre
St John's, Newfoundland and Labrador, Canada
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Cape Breton District Health Authority
Sydney, Nova Scotia, Canada
Canada, Ontario
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
University of Ottawa
Ottawa, Ontario, Canada
Timmins & District Hospital
Timmins, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Canada, Quebec
Charles Le Moyne Hospital
Greenfield Park, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Hôpital du Sacré-Coeur
Montreal, Quebec, Canada
Maisonneuve-Rosemont Hopital
Montréal, Quebec, Canada
CHUQ: L'Hôtel-Dieu de Québec
Quebec City, Quebec, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Adeera Levin University of British Columbia
  More Information

Publications:
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00826319     History of Changes
Other Study ID Numbers: H07-02457
Study First Received: January 20, 2009
Last Updated: November 27, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Chronic Kidney Disease
Renal Insufficiency
Biomarkers
Observational

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014