Status:
COMPLETED
The Canadian Prevention of Renal and Cardiovascular Endpoints Trial
Lead Sponsor:
Brendan Barrett
Collaborating Sponsors:
Nova Scotia Health Authority
Hopital Charles Lemoyne
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief 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 a...
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. Thes...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
474 Patients enrolled
Trial Details
Trial ID
NCT00231803
Start Date
April 1 2005
End Date
June 1 2008
Last Update
May 13 2022
Active Locations (5)
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1
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
2
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
3
Capitol District Health Authority
Halifax, Nova Scotia, Canada, B3H 1V8
4
London Health Sciences Centre
London, Ontario, Canada, N6A 4G3