Inflammatory Markers and Adverse Outcomes in Chronic Kidney Disease (AIMtoPREVENT)

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease

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 Type: Observational
• Enrollment (Actual): 2530

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in chronic kidney disease clinic setting

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal function at study censure	Estimated glomerular filtration rate after 3 years of follow-up in the study	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dialysis-dependent renal failure	Development of dialysis-dependent renal failure during observation period	3 years

Collaborators and Investigators

• Sponsor: Institute of Kidney Lifescience Technologies
• Investigators: Principal Investigator: Paul Y Tam, MD, Kidney Life Science Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2010
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: October 28, 2013
• First Submitted That Met QC Criteria: October 28, 2013
• First Posted (Estimate): November 1, 2013

Study Record Updates

• Last Update Posted (Actual): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Inflammation; FGF23; Genetic biomarkers; CKD progression
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 042010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED