Chronic Kidney DiseaseAIMtoPREVENTNCT01974713
Inflammatory Markers and Adverse Outcomes in Chronic Kidney Disease
An observational study of Chronic Kidney Disease, run by Institute of Kidney Lifescience Technologies.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 2,530 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Jul 2017
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in chronic kidney disease clinic setting
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
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.
- Conditions
- Chronic Kidney Disease
- Keywords
- CKD progression, Inflammation, FGF23, Genetic biomarkers
- Medical subject headings
- Renal Insufficiency, Chronic, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function at study censure
Estimated glomerular filtration rate after 3 years of follow-up in the study
Measured: 3 years
Secondary outcomes (1)
Dialysis-dependent renal failure
Development of dialysis-dependent renal failure during observation period
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startApr 2010
- Primary completionApr 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,530 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Institute of Kidney Lifescience Technologies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Y Tam, MD, Principal investigator, Kidney Life Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974713
- Sponsor's protocol ID
- 042010
- Acronym
- AIMtoPREVENT
- Status last verified
- Aug 2017
- First submitted
- 28 Oct 2013
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAN-AIM to PREVENT: CANadian Study, Assessing Inflammatory Markers to PRedict EVents in Nephrology sTudy
- ClinicalTrials.gov ID
- NCT01974713
- Acronym / sponsor ID
- AIMtoPREVENT / 042010
- Conditions
- Chronic Kidney Disease
- Keywords
- CKD progression, Inflammation, FGF23, Genetic biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,530 participants (actual)
- Lead sponsor
- Institute of Kidney Lifescience TechnologiesUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 1 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in chronic kidney disease clinic setting
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Renal function at study censure
Time frame: 3 years
Estimated glomerular filtration rate after 3 years of follow-up in the study
1 secondary outcome
Dialysis-dependent renal failure
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Y Tam, MD principal investigator
Kidney Life Science Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Institute of Kidney Lifescience Technologies.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function at study censure (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.