Overview

This trial is active, not recruiting.

Condition chronic kidney disease
Sponsor University of British Columbia
Start date June 2008
End date December 2014
Trial size 2602 participants
Trial identifier NCT00826319, H07-02457

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
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.
The original CanPreddict cohort was recruited from Jun 2008 - Oct 2009 has 2544 CKD patients across Canada.

Primary Outcomes

Measure
Renal Replacement Therapy
time frame: 6 monthly for 3 years, annually up to 5 years
Cardiovascular events
time frame: 6 monthly for 3 years, annually up to 5 years
Death
time frame: 6 monthly for 3 years, annually up to 5 years

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

Official title CanPREDDICT: Canadian Study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular Events Over Time
Principal investigator Adeera Levin
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by University of British Columbia.