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

• Conditions: Chronic Kidney Disease

• Registration Number: NCT00826319
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-01-20
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-22
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-27
• Last Update Posted: 2013-11-28
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2602

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Renal Replacement Therapy	6 monthly for 3 years, annually up to 5 years	Renal Replacement Therapy is defined as dialysis start or transplantation.
Cardiovascular events	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.
Death	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.

Trial Locations

Locations (25)

Foothills Hospital; 🇨🇦 Calgary, Alberta, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Penticton Regional Hospital; 🇨🇦 Penticton, British Columbia, 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, Canada

Eastern Regional Health Authority, Health Sciences Centre; 🇨🇦 St John's, Newfoundland and Labrador, Canada

QEII Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Cape Breton District Health Authority; 🇨🇦 Sydney, Nova Scotia, Canada

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