NCT01974713

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,530

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

6 years

First QC Date

October 28, 2013

Last Update Submit

August 31, 2017

Conditions

Chronic Kidney Disease

Keywords

CKD progressionInflammationFGF23Genetic biomarkers

Outcome Measures

Primary Outcomes (1)

  • Renal function at study censure

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

    3 years

Secondary Outcomes (1)

  • Dialysis-dependent renal failure

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in chronic kidney disease clinic setting

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Renal Insufficiency, ChronicInflammation

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Paul Y Tam, MD

    Kidney Life Science Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 1, 2013

Study Start

April 1, 2010

Primary Completion

April 1, 2016

Study Completion

July 1, 2017

Last Updated

September 1, 2017

Record last verified: 2017-08