The Canadian Prevention of Renal and Cardiovascular Endpoints Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Memorial University of Newfoundland.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canadian Diabetes Association
The Kidney Foundation of Canada
Heart and Stroke Foundation
Merck Frosst Canada Ltd.
Amgen
Janssen-Ortho Inc., Canada
Information provided by:
Memorial University of Newfoundland
ClinicalTrials.gov Identifier:
NCT00231803
First received: September 30, 2005
Last updated: October 6, 2005
Last verified: October 2005

September 30, 2005
October 6, 2005
April 2005
Not Provided
  • 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 to first major clinical event (ESRD, non-fatal cardiovascular events as in secondary (a) or all cause death)
Same as current
Complete list of historical versions of study NCT00231803 on ClinicalTrials.gov Archive Site
  • • # patients screened via lab
  • • # patients seen meeting eligibility criteria
  • • # patients enrolled over documented period
  • • OR similar assessment of the success of recruitment if non-laboratory based
  • • Description of baseline characteristics including care in place at study entry to compare to existing databases on clinic patients and community data
  • • Description of how the intervention is applied (by chart review, interviews and activity records)
  • • Assessment of the workload and study staff requirements
  • • The % of patients having a cardiovascular or kidney related clinical outcome event by one and two years of study
  • • The % of patients lost to follow-up each year from the experimental and control groups
  • • The % of patients in the experimental and control groups achieving targets for blood pressure, lipids, diabetes control, anemia, and mineral metabolism at six months, one and two years.
  • • The % of patients in the experimental and control groups smoking at six months, one and two years.
  • • The quality of life of those in the experimental and control groups at baseline, six, twelve and 24 months.
  • • The satisfaction with care received in the experimental and control groups
Same as current
Not Provided
Not Provided
 
The Canadian Prevention of Renal and Cardiovascular Endpoints Trial
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 kdiney disease. With the participation of these people, the study will test whether a nurse co-ordinated 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 heatlh care professionals will be studied to see how best to achieve good health outcomes.

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

  1. How long does it take to recruit 100 patients per study site?
  2. What recruitment strategies are most efficient?
  3. How do the baseline characteristics of those recruited compare to referred populations, and to the general population with CKD?
  4. How do the nephrologist and nurse work together to provide care to those in the intervention group?
  5. What is the nature of the care provided by the nurses and physicians to those in the intervention group?
  6. Is the study nurse able to manage the patient load?
  7. How much time and resources are needed to a) provide care, b) to carry out study measurements?
  8. Can health care resources used be measured for economic analysis?

Phase II

  1. What is the rate of loss to follow-up?
  2. What is the overall estimate of the primary outcome event rate?
  3. By one year of follow-up, what is the difference between the study groups in terms of:

    1. Protocol interventions used (estimates contamination)
    2. Proportion i) smoking; and proportion achieving ii) BP, iii) lipid, iv) diabetes, v) anemia, vi) acidosis, vii) mineral metabolism targets
    3. Quality of Life
    4. Satisfaction with care andomized, 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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Chronic Kidney Disease
  • Procedure: Combined CKD and CVD Prevention
  • Procedure: Cardiovascular Disease prevention
  • Procedure: Treatment of Chronic Kidney Disease complications
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2007
Not Provided

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Both
40 Years to 75 Years
No
Contact: Brendan J Barrett, MD (709) 777-8073 bbarrett@mun.ca
Contact: Patrick S Parfrey, MD (709) 777-7261 pparfrey@mun.ca
Canada
 
NCT00231803
HIC#04.154, CIHR Grant# NET-54003
Not Provided
Not Provided
Memorial University of Newfoundland
  • Canadian Institutes of Health Research (CIHR)
  • Canadian Diabetes Association
  • The Kidney Foundation of Canada
  • Heart and Stroke Foundation
  • Merck Frosst Canada Ltd.
  • Amgen
  • Janssen-Ortho Inc., Canada
Principal Investigator: Patrick S Parfrey, MD Memorial University of Newfoundland
Principal Investigator: Brendan J Barrett, MD Memorial University of Newfoundland
Memorial University of Newfoundland
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP