This is a multicentre study examining the use of Advagraf-minimization strategy and/or the use of an inhibitor of the renin-angiotensin system in reducing chronic rejection in renal allografts.
The study will consist of the following 4 treatment groups.: 1. Standard dose Advagraf with angiotensin-converting enzyme inhibitor (ACEi)/angiotensin receptor blocker (ARB) antihypertensive therapy 2. Standard dose Advagraf without ACEi/ARB antihypertensive therapy 3. Low dose Advagraf with ACEi/ARB antihypertensive therapy 4. Low dose Advagraf without ACEi/ARB antihypertensive therapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
281
Site CA133 Foothills Medical Centre
Calgary, Alberta, Canada
Site CA54 University of Alberta Hospital
Edmonton, Alberta, Canada
Site CA141 Health Sciences Centre
Percentage of Participants with the Presence of Allograft Interstitial Fibrosis and Tubular Atrophy (IF/TA) as Assessed at a Central Pathology Lab
Time frame: up to 24 months
Progression of IF/TA from Month 6 to Month 24
Time frame: up to 24 months
Time to T-cell Banff Mediated Rejection as Assessed at a Central Pathology Lab
Time frame: up to 24 months
Percentage of Participants in Each Category of Banff 2007 Diagnostic Classification of Renal Allograft Pathology
Time frame: up to 24 months
Percentage of Participants with Humoral Rejections
Time frame: up to 24 months
Percentage of Participants with Acute Rejections
Time frame: up to 24 months
Time to First Any Acute Rejection
Time frame: up to 24 months
Banff 2007 Individual Sub-scores
Banff 2007 sub-scores (AH = Arteriolar hyalinethickening score; AT = Tubulitis score; AV = Intimal arteritis score; AI = Interstitial inflammation score; AG = Glomerulitis score; CG = Glomerulopathy score; CI = Interstitial fibrosis score; CT = Tubularatrophy score; CV = Vascular fibrous intimal thickening score; MM = Mesangial matrix increase score; TI = Total interstitial inflammation score; PTC = Peritubulary capillaritis score) is measured on an ordinal scale of 0 - 3.
Time frame: up to 24 months
Change from Baseline in Chronic Allograft Damage Index
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Oral
IV and Oral
Oral
Oral
Winnipeg, Manitoba, Canada
Site CA114 Capital District Health Authority- QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Site CA150 St. Joseph's Healthcare
Hamilton, Ontario, Canada
Site CA27 London Health Sciences Centre
London, Ontario, Canada
Site CA165 St. Michael's Hospital
Toronto, Ontario, Canada
Site CA238 Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Site CA172 Hôpital Notre-Dame du CHUM
Montreal, Quebec, Canada
Site CA144 McGill University Health Centre
Montreal, Quebec, Canada
...and 3 more locations
Time frame: Baseline and 6, 24 months
Percentage of Participants with Circulating Anti-Donor Antibody
Time frame: up to 5 years
Number of Participants with Cellular Immune Response (ELISPOT)
Time frame: up to 6 months
Urine Renal Biomarkers
Time frame: up to 24 months
Graft Survival
Time frame: up to 5 years
Patient Survival
Time frame: up to 5 years
Renal Function as Measured by Glomerular Filtration Rate (GFR)
Time frame: up to 5 years
Renal Function as Measured by Serum Creatinine
Time frame: up to 5 years
Renal Function as Measured by Ratio of Urine Protein and Creatinine Concentrations
Time frame: up to 5 years
12-Item Short Form (SF-12) Health Survey: Physical Composite Score (PCS) and Mental Health Composite Score (MCS)
The PCS and MCS are measured on a normalized 0-100 scale and computed using the corresponding subdomains from the SF-12 with 0 being the lowest level of health and 100 the highest.
Time frame: up to 24 months
Kidney Transplant Recipient Opinions of Immunosuppressive Medications Questionnaire
This questionnaire consists of 11 questions regarding immunosuppressive medications, where questions 1-3 ask about your experiences and opinions of transplant anti-rejection medications, questions 4 and 11 ask to rate each medication on the scale of 1-10, with 1 meaning disagree completely and 10 meaning agree completely, and questions 5-10 ask which medication satisfies the question.
Time frame: up to 24 months
Percentage of Participants with Polyomavirus Infection
Time frame: up to 12 months