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

January 20, 2009
November 27, 2013
June 2008
December 2014   (final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT00826319 on ClinicalTrials.gov Archive Site
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Canadian Study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular Events Over Time
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum,Plasma,Urine, DNA and RNA

Non-Probability Sample

Nephrology Clinics across Canada

Chronic Kidney Disease
Not Provided
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2602
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00826319
H07-02457
No
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Adeera Levin University of British Columbia
University of British Columbia
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP