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

NCT ID: NCT00826319

Last Updated: 2013-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2602 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Chronic Kidney Disease

Keywords

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Chronic Kidney Disease Renal Insufficiency Biomarkers Observational

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Original CanPreddict cohort

The original CanPreddict cohort was recruited from Jun 2008 - Oct 2009 has 2544 CKD patients across Canada.

No interventions assigned to this group

Eligibility Criteria

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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
* Amputation (readings are inaccurate)
* Any battery operated or electronic implanted device (such as pacemaker or implanted defibrillator - potential electrical hazard)
* Pregnant women
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adeera Levin

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Foothills Hospital

Calgary, Alberta, Canada

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

Penticton Regional Hospital

Penticton, British Columbia, Canada

Site Status

BC Children's Hospital

Vancouver, British Columbia, Canada

Site Status

St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Site Status

Eastern Regional Health Authority, Health Sciences Centre

St. John's, Newfoundland and Labrador, Canada

Site Status

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Cape Breton District Health Authority

Sydney, Nova Scotia, Canada

Site Status

St Joseph's Hospital

Hamilton, Ontario, Canada

Site Status

Kingston General Hospital

Kingston, Ontario, Canada

Site Status

London Health Science Centre- University Campus

London, Ontario, Canada

Site Status

London Health Science Centre- Victoria Campus

London, Ontario, Canada

Site Status

York Central

Oak Ridges, Ontario, Canada

Site Status

University of Ottawa

Ottawa, Ontario, Canada

Site Status

Timmins & District Hospital

Timmins, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Sunnybrook Hospital

Toronto, Ontario, Canada

Site Status

University Health Network

Toronto, Ontario, Canada

Site Status

Charles Le Moyne Hospital

Greenfield Park, Quebec, Canada

Site Status

Hôpital du Sacré-Coeur

Montreal, Quebec, Canada

Site Status

Maisonneuve-Rosemont Hopital

Montreal, Quebec, Canada

Site Status

Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status

CHUQ: L'Hôtel-Dieu de Québec

Québec, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 23758910 (View on PubMed)

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.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 24371297 (View on PubMed)

Other Identifiers

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H07-02457

Identifier Type: -

Identifier Source: org_study_id