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

Chronic Kidney Disease Clinical Trial

— CanPREDDICT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00826319
• Other study ID #: H07-02457
• Status: Active, not recruiting
• Phase: N/A
• First received: January 20, 2009
• Last updated: November 27, 2013
• Start date: June 2008
• Est. completion date: December 2014

Study information

• Verified date: November 2013
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2602
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Canada	Foothills Hospital	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Charles Le Moyne Hospital	Greenfield Park	Quebec
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	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	Hôpital du Sacré-Coeur	Montreal	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	Maisonneuve-Rosemont Hopital	Montréal	Quebec
Canada	York Central	Oak Ridges	Ontario
Canada	University of Ottawa	Ottawa	Ontario
Canada	Penticton Regional Hospital	Penticton	British Columbia
Canada	CHUQ: L'Hôtel-Dieu de Québec	Quebec City	Quebec
Canada	Eastern Regional Health Authority, Health Sciences Centre	St John's	Newfoundland and Labrador
Canada	Cape Breton District Health Authority	Sydney	Nova Scotia
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	BC Children's Hospital	Vancouver	British Columbia
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	St. Boniface Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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 chron

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 Canadia — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal Replacement Therapy	Renal Replacement Therapy is defined as dialysis start or transplantation.	6 monthly for 3 years, annually up to 5 years	No
Primary	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	No
Primary	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	No