The Canadian Prevention of Renal and Cardiovascular Endpoints Trial

NCT00231803 | Completed DMC

• 1 other identifier: HIC#04.154
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Chronic Kidney Disease

Keywords

Cardiovascular; Prevention; RCT

Outcome Measures

Primary Outcomes (2)

• 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

  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

  24 months

Study Arms (2)

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

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

Other: Usual care

Interventions

Combined CKD and CVD Prevention OTHER

Perindopril, Lisinopril, Captopril, Candesartan, Losartan, Amlodipine, Verapamil, Chlorthalidone

Multifactorial intervention

Cardiovascular Disease prevention OTHER

Atorvastatin, Rosuvastatin, Simvastatin, Aspirin, Clopidogrel

Multifactorial intervention

Treatment of Chronic Kidney Disease complications OTHER

Calcitriol, Calcium carbonate, Erythropoietin, Sodium bicarbonate

Multifactorial intervention

Usual care OTHER

No prescribed intervention, just those that the patient's own family physician thought indicated

Usual care

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brendan Barrett: lead
• Nova Scotia Health Authority: collaborator
• Hopital Charles Lemoyne: collaborator
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator
• University of British Columbia: collaborator

Study Sites (5)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Capitol District Health Authority

Halifax, Nova Scotia, B3H 1V8, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G3, Canada

Location

Charles LeMoyne Hospital

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Related Publications (2)

• 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.

  PMID: 21617091 DERIVED

• Barrett 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.

  PMID: 21617090 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick S Parfrey, MD

  Memorial University of Newfoundland

  PRINCIPAL INVESTIGATOR

• Brendan J Barrett, MD

  Memorial University of Newfoundland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: April 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: by 2011
• Access Criteria: Indefinite

Locations

CA (5)