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

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ClinicalTrials.gov Identifier: NCT00826319
Recruitment Status : Unknown
Verified November 2013 by University of British Columbia.
Recruitment status was:  Active, not recruiting
First Posted : January 22, 2009
Last Update Posted : November 28, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Chronic Kidney Disease

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Study Type : Observational
Actual Enrollment : 2602 participants
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
Study Start Date : June 2008
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort
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.



Primary Outcome Measures :
  1. Renal Replacement Therapy [ Time Frame: 6 monthly for 3 years, annually up to 5 years ]
    Renal Replacement Therapy is defined as dialysis start or transplantation.

  2. Cardiovascular events [ Time Frame: 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.

  3. Death [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Serum,Plasma,Urine, DNA and RNA


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826319


Locations
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Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Adeera Levin University of British Columbia
Publications of Results:
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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00826319    
Other Study ID Numbers: H07-02457
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: November 28, 2013
Last Verified: November 2013
Keywords provided by University of British Columbia:
Chronic Kidney Disease
Renal Insufficiency
Biomarkers
Observational
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency