Inflammatory Markers and Adverse Outcomes in Chronic Kidney Disease

Completed

• Conditions: Chronic Kidney Disease

• Registration Number: NCT01974713
• Lead Sponsor: Institute of Kidney Lifescience Technologies

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-10-28
• Study First Posted: 2013-11-01
• Primary Completion: 2016-04
• Study Completion: 2017-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2530

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Renal function at study censure	3 years	Estimated glomerular filtration rate after 3 years of follow-up in the study

Secondary Outcome Measures

Name	Time	Method
Dialysis-dependent renal failure	3 years	Development of dialysis-dependent renal failure during observation period