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Clinical Trials/NCT01974713
NCT01974713CompletedNot Applicable

CAN-AIM to PREVENT: CANadian Study, Assessing Inflammatory Markers to PRedict EVents in Nephrology sTudy

Institute of Kidney Lifescience Technologies0 sites2,530 target enrollmentStarted: April 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
2,530
Primary Endpoint
Renal function at study censure

Study Overview

Brief Summary

Longitudinal cohort of patients with chronic kidney disease followed in 3 kidney centers in Ontario. The goal is to determine whether and how rates of renal disease progression are affected by inflammatory markers, FGF23 levels, and genetic polymorphisms

Detailed Description

This longitudinal cohort study will follow 2500 prevalent Chronic Kidney Disease (CKD)patients under the care of a nephrologist at 3 Southern Ontario Nephrology centres and all affiliated satellite centres with an estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min to determine the rate of their renal disease progression over a 36 months. All CKD patients older than 18 years of age may be included in this study. This study will analyze, with 6 month serial measurements, conventional biochemical, hormonal and metabolic parameters in addition to the demographics, clinical status, medications and blood and urine samples of these patients. This study will assess the influence of inflammation on FGF23 and genetic polymorphisms that may reflect the processes involved with disease progression.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients referred to a nephrologist for evaluation of CKD or those currently seen by a nephrologist, with eGFR less than 60 ml/min
  • Patients that are erythropoietin treatment naive
  • Transplant patients with failing grafts requiring nephrologists follow-up
  • Patients currently not receiving RRT consenting to be in the study
  • Adults 18 years of age and older

Exclusion Criteria

  • Functioning Organ transplant
  • Life expectancy less than 12 months
  • Patients currently receiving RRT or who will likely initiate RRT within 6 months
  • Patients unable or contraindicated to receive EPREX® as erythropoietin replacement therapy for the correction of anemia related to CKD

Outcomes

Primary Outcomes

Renal function at study censure

Time Frame: 3 years

Estimated glomerular filtration rate after 3 years of follow-up in the study

Secondary Outcomes

  • Dialysis-dependent renal failure(3 years)

Investigators

Sponsor
Institute of Kidney Lifescience Technologies
Sponsor Class
Other
Responsible Party
Sponsor

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