Inflammatory Markers and Adverse Outcomes in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

— AIMtoPREVENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974713
• Other study ID #: 042010
• Status: Completed
• Phase: N/A
• First received: October 28, 2013
• Last updated: August 31, 2017
• Start date: April 2010
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: Institute of Kidney Lifescience Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2530
• Est. completion date: July 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Kidney Lifescience Technologies

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function at study censure	Estimated glomerular filtration rate after 3 years of follow-up in the study	3 years
Secondary	Dialysis-dependent renal failure	Development of dialysis-dependent renal failure during observation period	3 years