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CompletedNCT01974713AIMtoPREVENTUpdated Sep 1, 2017

Inflammatory Markers and Adverse Outcomes in Chronic Kidney Disease

An observational study in Chronic Kidney Disease, sponsored by Institute of Kidney Lifescience Technologies. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-01.

Sponsored by Institute of Kidney Lifescience Technologies · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,530
Ages
18 Years and older
Sex
All
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Study 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

Read the 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.

02

Conditions studied

  • Chronic Kidney Disease

Keywords

  • CKD progression
  • Inflammation
  • FGF23
  • Genetic biomarkers
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 2,530 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

This is the only study on the registry with Institute of Kidney Lifescience Technologies as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients in chronic kidney disease clinic setting

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,530 participants (actual)
Target follow-up
3 Years
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Renal function at study censure

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

    Time frame: 3 years

Secondary outcomes

  1. Dialysis-dependent renal failure

    Development of dialysis-dependent renal failure during observation period

    Time frame: 3 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01974713
Lead sponsor
Institute of Kidney Lifescience Technologies
Responsible party
Sponsor
First posted
Nov 1, 2013
Start date
Apr 2010
Primary completion
Apr 2016
Completion
Jul 2017
Last update
Sep 1, 2017

Study contacts

Paul Y Tam, MD
principal investigator · Kidney Life Science Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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