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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00826319

Acronym

CanPREDDICT

Enrollment

2602

Registered

2009-01-22

Start date

2008-06-30

Completion date

2014-12-31

Last updated

2013-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease, Renal Insufficiency, Biomarkers, Observational

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Canada

Outcome results