Chronic Kidney DiseaseCanPreventNCT00231803
The Canadian Prevention of Renal and Cardiovascular Endpoints Trial
A study testing Combined CKD and CVD Prevention, Cardiovascular Disease prevention and Treatment of Chronic Kidney Disease complications in people with Chronic Kidney Disease, run by Brendan Barrett at 5 sites in Canada.
Trial summary
Advanced kidney disease with it's associated heart and blood vessel problems are becoming more frequent. These problems markedly affect length and quality of life and cost a lot to treat. Treatments are known that can prevent development of advanced kidney and heart disease. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Combined CKD and CVD Prevention, Cardiovascular Disease prevention and Treatment of Chronic Kidney Disease complications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 5 sitesCanada
- Study dates
- Apr 2005to Jun 2008
- Phase
- Interventional
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stratum 1 (expected about 50% of trial subjects): Diabetes mellitus (by clinical history with documented prior plasma glucose levels in the diabetic range, or on hypoglycemic medications) and CKD as documented by calculated (Cockroft-Gault equation) creatinine clearance between 25 and 60 mls/min/1.73m2 derived from the screening serum creatinine value and the next most recent known value from more than 2 weeks prior; OR
- Stratum 2 (expected about 20% of trial subjects): Non-diabetic with CKD as defined for Stratum 1 and proteinuria of > 1g/L by dipstick in random urine at screening; OR
- Stratum 3 (expected about 30% of trial subjects): Non-diabetic with CKD as defined for stratum 1, but without proteinuria as for stratum 2 at screening
Who cannot join
- Unwilling to provide informed consent
- Likely to die of any known existing disease within 6 months
- Recently unstable/advanced cardiovascular disease (MI or acute coronary syndrome, hospitalized heart failure, TIA or stroke, leg amputation or gangrene in past 6 months)
- Currently receiving active treatment for a malignant, neoplastic disease other than localized non-melanoma skin cancer
- Progressive kidney disease currently treated by immunotherapy
- Currently receiving dialysis or likely to do so within 6 months
Show all 10Show fewer
- Current organ transplant recipient (or planned within 6 months)
- Currently receiving ongoing care for CKD, or cardiovascular disease, in a multiple intervention, disease management program.
- Currently enrolled in another interventional trial
- Residing in a location not amenable to follow up for the trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Charles LeMoyne Hospital
Greenfield Park, Quebec, J4V 2H1
Capitol District Health Authority
Halifax, Nova Scotia, B3H 1V8
London Health Sciences Centre
London, Ontario, N6A 4G3
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, A1B 3V6
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Canadian Collaborative Group for the Prevention of Illness in Chronic Renal Disease: The Canadian Prevention of Renal and Cardiovascular Endpoints Trial
Advanced kidney disease with it's associated heart and blood vessel problems are becoming more frequent. These problems markedly affect length and quality of life and cost a lot to treat. Treatments are known that can prevent development of advanced kidney and heart disease. These treatments are not being optimally applied in the current health system. This study aims to identify people with relatively early stage chronic kidney disease. With the participation of these people, the study will test whether a nurse coordinated clinic involving a medical kidney specialist, applying the known treatments, can reduce or delay the onset of advanced kidney disease and heart and blood vessel problems such as heart attack, stroke and death, to a greater extent than usual care. The study will also address issues of costs associated with care and illness. The nature of the care provided by the health care professionals will be studied to see how best to achieve good health outcomes.
Read the detailed description
The pilot study is designed in two phases. The first phase is intended to provide data on some key points that need to be addressed prior to future funding applications to the CIHR and the NHLBI. These applications are currently tentatively planned for the fall of 2005. The second phase of the pilot study is intended to more completely establish the feasibility of successfully completing the full trial by examining the issue of contamination and the ability of the intervention to generate a difference between the groups with regard to use of efficacious therapies and control of modifiable risk factors, or intermediate variables on the causal pathway to the clinical end-points in the full-scale trial. The second phase will also address the need to describe the operation of the experimental intervention more thoroughly. Finally, the second phase of the pilot study will compare the randomized study groups with regard to short-term quality-of-life outcomes.
Phase1
- How long does it take to recruit 100 patients per study site?
- What recruitment strategies are most efficient?
- How do the baseline characteristics of those recruited compare to referred populations, and to the general population with CKD?
- How do the nephrologist and nurse work together to provide care to those in the intervention group?
- What is the nature of the care provided by the nurses and physicians to those in the intervention group?
- Is the study nurse able to manage the patient load?
- How much time and resources are needed to a) provide care, b) to carry out study measurements?
- Can health care resources used be measured for economic analysis?
Phase II
- What is the rate of loss to follow-up?
- What is the overall estimate of the primary outcome event rate?
- By one year of follow-up, what is the difference between the study groups in terms of:
- Protocol interventions used (estimates contamination)
- Proportion i) smoking; and proportion achieving ii) BP, iii) lipid, iv) diabetes, v) anemia, vi) acidosis, vii) mineral metabolism targets
- Quality of Life
- Satisfaction with care Randomized, parallel, two group, multicentre, clinical trial of people with CKD, with or without diabetes mellitus or proteinuria. The intention is to roll the pilot study into the full-scale trial if the pilot itself is deemed successful. A laboratory-based case finding method will be used preferentially to identify potential participants. This will be supplemented by practice-based case-finding approaches where necessary to ensure recruitment of a representative population. Randomization will be by a central computer-based telephone process. Stratification will be by center and presence of diabetes and proteinuria. The intervention consists of a protocol guided, multiple risk factor and chronic disease care model-like approach delivered by a trained nurse supported by a nephrologist and will be based in a nephrology clinic like setting.
- Conditions
- Chronic Kidney Disease
- Being tested
- Combined CKD and CVD Prevention, Cardiovascular Disease prevention, Treatment of Chronic Kidney Disease complications, Usual care
- Keywords
- Cardiovascular, Prevention, RCT
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined CKD and CVD PreventionOther
Perindopril, Lisinopril, Captopril, Candesartan, Losartan, Amlodipine, Verapamil, Chlorthalidone
Cardiovascular Disease preventionOther
Atorvastatin, Rosuvastatin, Simvastatin, Aspirin, Clopidogrel
Treatment of Chronic Kidney Disease complicationsOther
Calcitriol, Calcium carbonate, Erythropoietin, Sodium bicarbonate
Usual careOther
No prescribed intervention, just those that the patient's own family physician thought indicated
| Study group | Role | What they receive |
|---|---|---|
| Multifactorial intervention | Experimental | Nurse led clinic involving a nephrologist administering protocol driven interventions aimed at preservation of kidney function, and cardiovascular risk reduction. Blood pressure targets were specified. No specific drugs were specified. Drug classes such as primarily statins for achieving LDL targets, use of an ACE inhibitor or ARB if possible, treatment of acidosis, anemia, hyperphosphatemia, advice on smoking cessation Receives: Other: Combined CKD and CVD Prevention; Other: Cardiovascular Disease prevention; Other: Treatment of Chronic Kidney Disease complications |
| Usual care | Active comparator | Usual care includes any intervention thought appropriate by the treating family doctor and or specialists involved in the case Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to major cardiovascular event(myocardial infarction, stroke, coronary or peripheral revascularization, hospitalization for heart failure or unstable angina, or death due to cardiovascular cause)
Blind expert panel determined major cardiovascular events or death
Measured: 24 months
Time to first major clinical event (ESRD, non-fatal cardiovascular events as in secondary (a) or all cause death)
Blind expert panel determined major cardiovascular event, death or end stage renal disease
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startApr 2005
- Primary completionMay 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brendan Barrett
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Scotia Health Authority, Hopital Charles Lemoyne, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, University of British Columbia
- Responsible party
- Sponsor-investigator, Brendan Barrett, Memorial University of Newfoundland
- Investigators
- Patrick S Parfrey, MD, Principal investigator, Memorial University of NewfoundlandBrendan J Barrett, MD, Principal investigator, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231803
- Sponsor's protocol ID
- HIC#04.154
- Acronym
- CanPrevent
- Status last verified
- May 2022
- First submitted
- 30 Sep 2005
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Publication of study design and results in open access
Publications
Hopkins RB, Garg AX, Levin A, Molzahn A, Rigatto C, Singer J, Soltys G, Soroka S, Parfrey PS, Barrett BJ, Goeree R. Cost-effectiveness analysis of a randomized trial comparing care models for chronic kidney disease. Clin J Am Soc Nephrol. 2011 Jun;6(6):1248-57. doi: 10.2215/CJN.07180810. Epub 2011 May 26.
PubMed 21617091Barrett BJ, Garg AX, Goeree R, Levin A, Molzahn A, Rigatto C, Singer J, Soltys G, Soroka S, Ayers D, Parfrey PS. A nurse-coordinated model of care versus usual care for stage 3/4 chronic kidney disease in the community: a randomized controlled trial. Clin J Am Soc Nephrol. 2011 Jun;6(6):1241-7. doi: 10.2215/CJN.07160810. Epub 2011 May 26.
PubMed 21617090
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Collaborative Group for the Prevention of Illness in Chronic Renal Disease: The Canadian Prevention of Renal and Cardiovascular Endpoints Trial
- ClinicalTrials.gov ID
- NCT00231803
- Acronym / sponsor ID
- CanPrevent / HIC#04.154
- Conditions
- Chronic Kidney Disease
- Keywords
- Cardiovascular, Prevention, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Brendan BarrettUniversity, hospital or other
- Collaborators
- Nova Scotia Health Authority, Hopital Charles Lemoyne, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, University of British Columbia
- Study start
- Apr 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 4 Oct 2005 (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.
Advanced kidney disease with it's associated heart and blood vessel problems are becoming more frequent. These problems markedly affect length and quality of life and cost a lot to treat. Treatments are known that can prevent development of advanced kidney and heart disease. These treatments are not being optimally applied in the current health system. This study aims to identify people with relatively early stage chronic kidney disease. With the participation of these people, the study will test whether a nurse coordinated clinic involving a medical kidney specialist, applying the known treatments, can reduce or delay the onset of advanced kidney disease and heart and blood vessel problems such as heart attack, stroke and death, to a greater extent than usual care. The study will also address issues of costs associated with care and illness. The nature of the care provided by the health care professionals will be studied to see how best to achieve good health outcomes.
Detailed description
The pilot study is designed in two phases. The first phase is intended to provide data on some key points that need to be addressed prior to future funding applications to the CIHR and the NHLBI. These applications are currently tentatively planned for the fall of 2005. The second phase of the pilot study is intended to more completely establish the feasibility of successfully completing the full trial by examining the issue of contamination and the ability of the intervention to generate a difference between the groups with regard to use of efficacious therapies and control of modifiable risk factors, or intermediate variables on the causal pathway to the clinical end-points in the full-scale trial. The second phase will also address the need to describe the operation of the experimental intervention more thoroughly. Finally, the second phase of the pilot study will compare the randomized study groups with regard to short-term quality-of-life outcomes.
Phase1
- How long does it take to recruit 100 patients per study site?
- What recruitment strategies are most efficient?
- How do the baseline characteristics of those recruited compare to referred populations, and to the general population with CKD?
- How do the nephrologist and nurse work together to provide care to those in the intervention group?
- What is the nature of the care provided by the nurses and physicians to those in the intervention group?
- Is the study nurse able to manage the patient load?
- How much time and resources are needed to a) provide care, b) to carry out study measurements?
- Can health care resources used be measured for economic analysis?
Phase II
- What is the rate of loss to follow-up?
- What is the overall estimate of the primary outcome event rate?
- By one year of follow-up, what is the difference between the study groups in terms of:
- Protocol interventions used (estimates contamination)
- Proportion i) smoking; and proportion achieving ii) BP, iii) lipid, iv) diabetes, v) anemia, vi) acidosis, vii) mineral metabolism targets
- Quality of Life
- Satisfaction with care Randomized, parallel, two group, multicentre, clinical trial of people with CKD, with or without diabetes mellitus or proteinuria. The intention is to roll the pilot study into the full-scale trial if the pilot itself is deemed successful. A laboratory-based case finding method will be used preferentially to identify potential participants. This will be supplemented by practice-based case-finding approaches where necessary to ensure recruitment of a representative population. Randomization will be by a central computer-based telephone process. Stratification will be by center and presence of diabetes and proteinuria. The intervention consists of a protocol guided, multiple risk factor and chronic disease care model-like approach delivered by a trained nurse supported by a nephrologist and will be based in a nephrology clinic like setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifactorial intervention | Experimental | Other: Combined CKD and CVD Prevention, Other: Cardiovascular Disease prevention, Other: Treatment of Chronic Kidney Disease complicationsNurse led clinic involving a nephrologist administering protocol driven interventions aimed at preservation of kidney function, and cardiovascular risk reduction. Blood pressure targets were specified. No specific drugs were specified. Drug classes such as primarily statins for achieving LDL targets, use of an ACE inhibitor or ARB if possible, treatment of acidosis, anemia, hyperphosphatemia, advice on smoking cessation |
| Usual care | Active comparator | Other: Usual careUsual care includes any intervention thought appropriate by the treating family doctor and or specialists involved in the case |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stratum 1 (expected about 50% of trial subjects): Diabetes mellitus (by clinical history with documented prior plasma glucose levels in the diabetic range, or on hypoglycemic medications) and CKD as documented by calculated (Cockroft-Gault equation) creatinine clearance between 25 and 60 mls/min/1.73m2 derived from the screening serum creatinine value and the next most recent known value from more than 2 weeks prior; OR
- Stratum 2 (expected about 20% of trial subjects): Non-diabetic with CKD as defined for Stratum 1 and proteinuria of > 1g/L by dipstick in random urine at screening; OR
- Stratum 3 (expected about 30% of trial subjects): Non-diabetic with CKD as defined for stratum 1, but without proteinuria as for stratum 2 at screening
Key exclusion criteria (10 listed)
- Unwilling to provide informed consent
- Likely to die of any known existing disease within 6 months
- Recently unstable/advanced cardiovascular disease (MI or acute coronary syndrome, hospitalized heart failure, TIA or stroke, leg amputation or gangrene in past 6 months)
- Currently receiving active treatment for a malignant, neoplastic disease other than localized non-melanoma skin cancer
- Progressive kidney disease currently treated by immunotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined CKD and CVD PreventionPerindopril, Lisinopril, Captopril, Candesartan, Losartan, Amlodipine, Verapamil, Chlorthalidone | Other | Multifactorial intervention |
| Cardiovascular Disease preventionAtorvastatin, Rosuvastatin, Simvastatin, Aspirin, Clopidogrel | Other | Multifactorial intervention |
| Treatment of Chronic Kidney Disease complicationsCalcitriol, Calcium carbonate, Erythropoietin, Sodium bicarbonate | Other | Multifactorial intervention |
| Usual careNo prescribed intervention, just those that the patient's own family physician thought indicated | Other | Usual care |
Primary outcome
Time to major cardiovascular event(myocardial infarction, stroke, coronary or peripheral revascularization, hospitalization for heart failure or unstable angina, or death due to cardiovascular cause)
Time frame: 24 months
Blind expert panel determined major cardiovascular events or death
Time to first major clinical event (ESRD, non-fatal cardiovascular events as in secondary (a) or all cause death)
Time frame: 24 months
Blind expert panel determined major cardiovascular event, death or end stage renal disease
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 13 May 2022.
- Derived from this study: PubMed 21617091Hopkins RB, Garg AX, Levin A, Molzahn A, Rigatto C, Singer J, Soltys G, Soroka S, Parfrey PS, Barrett BJ, Goeree R. Cost-effectiveness analysis of a randomized trial comparing care models for chronic kidney disease. Clin J Am Soc Nephrol. 2011 Jun;6(6):1248-57. doi: 10.2215/CJN.07180810. Epub 2011 May 26.
- Derived from this study: PubMed 21617090Barrett BJ, Garg AX, Goeree R, Levin A, Molzahn A, Rigatto C, Singer J, Soltys G, Soroka S, Ayers D, Parfrey PS. A nurse-coordinated model of care versus usual care for stage 3/4 chronic kidney disease in the community: a randomized controlled trial. Clin J Am Soc Nephrol. 2011 Jun;6(6):1241-7. doi: 10.2215/CJN.07160810. Epub 2011 May 26.
- Individual participant dataSharing planned: Yes. Publication of study design and results in open access
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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.
Patrick S Parfrey, MD principal investigator
Memorial University of Newfoundland
Brendan J Barrett, MD principal investigator
Memorial University of Newfoundland
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined CKD and CVD Prevention, Cardiovascular Disease prevention and Treatment of Chronic Kidney Disease complications in people with Chronic Kidney Disease, run by Brendan Barrett at 5 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 3 inclusion and 10 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 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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?
Time to major cardiovascular event(myocardial infarction, stroke, coronary or peripheral revascularization, hospitalization for heart failure or unstable angina, or death due to cardiovascular cause) (time frame: 24 months). The study lists 2 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 NCT00231803, which also lists 2 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 13 May 2022.