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Completed

NCT Number: NCT01974713

Inflammatory Markers and Adverse Outcomes in Chronic Kidney Disease

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Renal function at study censure

    Time frame: 3 years

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

Secondary outcomes

  1. Dialysis-dependent renal failure

    Time frame: 3 years

    Development of dialysis-dependent renal failure during observation period

Sponsors and collaborators

Lead sponsor

Institute of Kidney Lifescience Technologies

Other

Registry information

Official study title

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

Acronym: AIMtoPREVENT

Important dates

Study start
2010
Primary completion
2016
Study completion
2017
First posted
Nov 1, 2013
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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