NCT00826319

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,602

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

25 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 28, 2013

Status Verified

November 1, 2013

Enrollment Period

6.5 years

First QC Date

January 20, 2009

Last Update Submit

November 27, 2013

Conditions

Keywords

Chronic Kidney DiseaseRenal InsufficiencyBiomarkersObservational

Outcome Measures

Primary Outcomes (3)

  • Renal Replacement Therapy

    Renal Replacement Therapy is defined as dialysis start or transplantation.

    6 monthly for 3 years, annually up to 5 years

  • Cardiovascular events

    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.

    6 monthly for 3 years, annually up to 5 years

  • Death

    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.

    6 monthly for 3 years, annually up to 5 years

Study Arms (3)

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 Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Nephrology Clinics across Canada

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Foothills Hospital

Calgary, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

Penticton Regional Hospital

Penticton, British Columbia, Canada

Location

BC Children's Hospital

Vancouver, British Columbia, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Location

Eastern Regional Health Authority, Health Sciences Centre

St. John's, Newfoundland and Labrador, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Cape Breton District Health Authority

Sydney, Nova Scotia, Canada

Location

St Joseph's Hospital

Hamilton, Ontario, Canada

Location

Kingston General Hospital

Kingston, Ontario, Canada

Location

London Health Science Centre- University Campus

London, Ontario, Canada

Location

London Health Science Centre- Victoria Campus

London, Ontario, Canada

Location

York Central

Oak Ridges, Ontario, Canada

Location

University of Ottawa

Ottawa, Ontario, Canada

Location

Timmins & District Hospital

Timmins, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Hospital

Toronto, Ontario, Canada

Location

University Health Network

Toronto, Ontario, Canada

Location

Charles Le Moyne Hospital

Greenfield Park, Quebec, Canada

Location

Hôpital du Sacré-Coeur

Montreal, Quebec, Canada

Location

Maisonneuve-Rosemont Hopital

Montreal, Quebec, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, Canada

Location

CHUQ: L'Hôtel-Dieu de Québec

Québec, Quebec, Canada

Location

Related Publications (3)

  • 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.

  • 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.

    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.

Biospecimen

Retention: SAMPLES WITH DNA

Serum,Plasma,Urine, DNA and RNA

MeSH Terms

Conditions

Renal Insufficiency, ChronicRenal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Adeera Levin

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 22, 2009

Study Start

June 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

November 28, 2013

Record last verified: 2013-11

Locations