Chronic Kidney DiseaseCanPREDDICTNCT00826319
Canadian Study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular Events Over Time
An observational study of Chronic Kidney Disease, run by University of British Columbia at 25 sites in Canada.
Trial summary
This study will follow 2500 prevalent Chronic Kidney Disease (CKD) patients with Glomerular Filtration Rate (GFR) from 15-45 ml/min for 30 months with serial measurements every 6 months and subsequent annual chart review up to 60 months. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 2,602 participants
- Where
- 25 sitesCanada
- Study dates
- Jun 2008to Dec 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Nephrology Clinics across Canada
Who may be able to join
- Patients currently seen by a nephrologist, or referred for evaluation of CKD
- GFR between 15-45 ml/min
- Adults 19 years (depending on age of consent in province) or older
- At pediatric sites study participants will be eligible to participate at age 15 or older
Who cannot join
- Organ transplant recipient
- Life expectancy less than 12 months
- Acute Vasculitis
- Bioimpedance sub-study exclusion criteria:
- Amputation (readings are inaccurate)
- Any battery operated or electronic implanted device (such as pacemaker or implanted defibrillator - potential electrical hazard)
- Pregnant women
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Canada25 sites
Foothills Hospital
Calgary, Alberta
University of Alberta
Edmonton, Alberta
Charles Le Moyne Hospital
Greenfield Park, Quebec
QEII Health Sciences Centre
Halifax, Nova Scotia
St Joseph's Hospital
Hamilton, Ontario
Kingston General Hospital
Kingston, Ontario
London Health Science Centre- University Campus
London, Ontario
London Health Science Centre- Victoria Campus
London, Ontario
Hôpital du Sacré-Coeur
Montreal, Quebec
Maisonneuve-Rosemont Hopital
Montreal, Quebec
Royal Victoria Hospital
Montreal, Quebec
York Central
Oak Ridges, Ontario
University of Ottawa
Ottawa, Ontario
Penticton Regional Hospital
Penticton, British Columbia
CHUQ: L'Hôtel-Dieu de Québec
Québec, Quebec
Eastern Regional Health Authority, Health Sciences Centre
St. John's, Newfoundland and Labrador
Cape Breton District Health Authority
Sydney, Nova Scotia
Timmins & District Hospital
Timmins, Ontario
St. Michael's Hospital
Toronto, Ontario
Sunnybrook Hospital
Toronto, Ontario
University Health Network
Toronto, Ontario
BC Children's Hospital
Vancouver, British Columbia
St. Paul's Hospital
Vancouver, British Columbia
Vancouver General Hospital
Vancouver, British Columbia
St. Boniface Hospital
Winnipeg, Manitoba
About this study
Official title: CanPREDDICT: Canadian Study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular Events Over Time
This study will follow 2500 prevalent Chronic Kidney Disease (CKD) patients with Glomerular Filtration Rate (GFR) from 15-45 ml/min for 30 months with serial measurements every 6 months and subsequent annual chart review up to 60 months. This observational study will analyze the demographics, clinical status, medications and blood and urine samples of these patients and study the conventional biochemical, hormonal and metabolic parameters assessing which underlying biomarkers reflect the processes involved with disease progression.
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Renal Insufficiency, Biomarkers, Observational
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bioimpedance sub-study cohort | Funded by a grant from Kidney Foundation of Canada, Dr. Catherine Clase initiated a bioimpedance sub-study across 7 centres and recruited n=416 within the CANPREDDICT population. The study uses bioimpedance measurements to assess volume status to determine the multivariable relationship between baseline volume overload and subsequent cardiovascular events. Subjects are followed at 6 months intervals for 2 years. | |
| Ethnic enrichment cohort | Additional recruitment initiated and funded by the Principal Investigator, Adeera Levin for enriching the ethnic representation within the Canadian cohort on South Asian and Oriental Asian was completed from Sept 2012 to June 2013, n=53. | |
| Original CanPreddict cohort | The original CanPreddict cohort was recruited from Jun 2008 - Oct 2009 has 2544 CKD patients across Canada. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Replacement Therapy
Renal Replacement Therapy is defined as dialysis start or transplantation.
Measured: 6 monthly for 3 years, annually up to 5 years
Cardiovascular events
Cardiovascular events are defined as myocardial infarction, ischemic and hemorrhagic stroke, coronary revascularization, congestive heart failure, peripheral bypass and gangrenes, adjudicated by a nephrologist, cardiologist and neurologist.
Measured: 6 monthly for 3 years, annually up to 5 years
Death
Deaths are reported with source documentation and adjudicated for ischemic or congestive cardiovascular death, other cardiovascular death, non-cardiovascular death and unknown cause of death.
Measured: 6 monthly for 3 years, annually up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJun 2008
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- 2,602 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeera Levin, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826319
- Sponsor's protocol ID
- H07-02457
- Acronym
- CanPREDDICT
- Status last verified
- Nov 2013
- First submitted
- 20 Jan 2009
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Levin A, Rigatto C, Brendan B, Madore F, Muirhead N, Holmes D, Clase CM, Tang M, Djurdjev O; CanPREDDICT investigators. Cohort profile: Canadian study of prediction of death, dialysis and interim cardiovascular events (CanPREDDICT). BMC Nephrol. 2013 Jun 11;14:121. doi: 10.1186/1471-2369-14-121.
PubMed 23758910Levin A, Rigatto C, Barrett B, Madore F, Muirhead N, Holmes D, Clase C, Tang M, Djurdjev O. (2012). Canadian study of prediciont of death, dialysis and interim cardiovascular events: CanPREDDICT: Biomarkers improve prediction of one year outcomes in chronic kidney disease cohort. Clinical studies in CKD. Nephrology Dialysis Transplantation, 27(suppl 2), ii63-ii65.
Levin A, Rigatto C, Barrett B, Madore F, Muirhead N, Holmes D, Clase CM, Tang M, Djurdjev O; CanPREDDICT Investigators. Biomarkers of inflammation, fibrosis, cardiac stretch and injury predict death but not renal replacement therapy at 1 year in a Canadian chronic kidney disease cohort. Nephrol Dial Transplant. 2014 May;29(5):1037-47. doi: 10.1093/ndt/gft479. Epub 2013 Dec 26.
PubMed 24371297
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CanPREDDICT: Canadian Study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular Events Over Time
- ClinicalTrials.gov ID
- NCT00826319
- Acronym / sponsor ID
- CanPREDDICT / H07-02457
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Renal Insufficiency, Biomarkers, Observational
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,602 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 22 Jan 2009 (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.
This study will follow 2500 prevalent Chronic Kidney Disease (CKD) patients with Glomerular Filtration Rate (GFR) from 15-45 ml/min for 30 months with serial measurements every 6 months and subsequent annual chart review up to 60 months. This observational study will analyze the demographics, clinical status, medications and blood and urine samples of these patients and study the conventional biochemical, hormonal and metabolic parameters assessing which underlying biomarkers reflect the processes involved with disease progression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bioimpedance sub-study cohort | – | –Funded by a grant from Kidney Foundation of Canada, Dr. Catherine Clase initiated a bioimpedance sub-study across 7 centres and recruited n=416 within the CANPREDDICT population. The study uses bioimpedance measurements to assess volume status to determine the multivariable relationship between baseline volume overload and subsequent cardiovascular events. Subjects are followed at 6 months intervals for 2 years. |
| Ethnic enrichment cohort | – | –Additional recruitment initiated and funded by the Principal Investigator, Adeera Levin for enriching the ethnic representation within the Canadian cohort on South Asian and Oriental Asian was completed from Sept 2012 to June 2013, n=53. |
| Original CanPreddict cohort | – | –The original CanPreddict cohort was recruited from Jun 2008 - Oct 2009 has 2544 CKD patients across Canada. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nephrology Clinics across Canada
Key inclusion criteria (4 listed)
- Patients currently seen by a nephrologist, or referred for evaluation of CKD
- GFR between 15-45 ml/min
- Adults 19 years (depending on age of consent in province) or older
- At pediatric sites study participants will be eligible to participate at age 15 or older
Key exclusion criteria (7 listed)
- Organ transplant recipient
- Life expectancy less than 12 months
- Acute Vasculitis
- Bioimpedance sub-study exclusion criteria:
- Amputation (readings are inaccurate)
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 Replacement Therapy
Time frame: 6 monthly for 3 years, annually up to 5 years
Renal Replacement Therapy is defined as dialysis start or transplantation.
Cardiovascular events
Time frame: 6 monthly for 3 years, annually up to 5 years
Cardiovascular events are defined as myocardial infarction, ischemic and hemorrhagic stroke, coronary revascularization, congestive heart failure, peripheral bypass and gangrenes, adjudicated by a nephrologist, cardiologist and neurologist.
Death
Time frame: 6 monthly for 3 years, annually up to 5 years
Deaths are reported with source documentation and adjudicated for ischemic or congestive cardiovascular death, other cardiovascular death, non-cardiovascular death and unknown cause of death.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
- Results publication: PubMed 23758910Levin A, Rigatto C, Brendan B, Madore F, Muirhead N, Holmes D, Clase CM, Tang M, Djurdjev O; CanPREDDICT investigators. Cohort profile: Canadian study of prediction of death, dialysis and interim cardiovascular events (CanPREDDICT). BMC Nephrol. 2013 Jun 11;14:121. doi: 10.1186/1471-2369-14-121.
- Results publicationLevin A, Rigatto C, Barrett B, Madore F, Muirhead N, Holmes D, Clase C, Tang M, Djurdjev O. (2012). Canadian study of prediciont of death, dialysis and interim cardiovascular events: CanPREDDICT: Biomarkers improve prediction of one year outcomes in chronic kidney disease cohort. Clinical studies in CKD. Nephrology Dialysis Transplantation, 27(suppl 2), ii63-ii65.
- Results publication: PubMed 24371297Levin A, Rigatto C, Barrett B, Madore F, Muirhead N, Holmes D, Clase CM, Tang M, Djurdjev O; CanPREDDICT Investigators. Biomarkers of inflammation, fibrosis, cardiac stretch and injury predict death but not renal replacement therapy at 1 year in a Canadian chronic kidney disease cohort. Nephrol Dial Transplant. 2014 May;29(5):1037-47. doi: 10.1093/ndt/gft479. Epub 2013 Dec 26.
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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.
Adeera Levin principal investigator
University of British Columbia
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by University of British Columbia at 25 sites in Canada.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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 Replacement Therapy (time frame: 6 monthly for 3 years, annually up to 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00826319, which also lists 3 linked publications.
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 28 Nov 2013.