Status:
COMPLETED
Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Canada, Inc.
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Subject is the recipient of a first or second deceased or living donor renal transplant (one kidney only)
- Subject must have at least one HLA-mismatch with the donor. HLA identical donor-recipient pairs are not eligible
- Subject understands either English or French
- If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods
Exclusion
- Presence of donor specific antibody
- Subject who is currently participating in a study with investigational drug, or who has received investigational drug within three months prior to randomization. Observational studies are acceptable
- Subject who has lost a previous graft for immunological reasons less than one year from transplant
- Subject is pregnant or breastfeeding
- Subject receives a kidney lacking pre-implantation biopsy
- Subject has significant disease (e.g. malignancy or uncontrolled infection) or disability (e.g. cognitive defect) which prevents understanding of, or adherence to the protocol
- Subject who in the opinion of the Investigator, require ACEi/ARB therapy post-transplant for any indication
- Subject who requires induction with Thymoglobulin, Campath, antithymocyte globulin (ATG), antilymphocyte globulin (ALG) or any biological induction agent other than basiliximab. Unplanned post-transplant use of these prohibited drugs for clinical indications post-transplant is allowed
- Subject has plans to become pregnant within 2 years post-transplant
- Subject who has a positive T-cell or B-cell crossmatch. Subjects with a weakly positive B-cell cross-match that tests negative following DTT reduction are acceptable
- Subject who has a requirement for maintenance immunosuppressant therapy with the exception of low dose steroid or mycophenolate mofetil (MMF). A subject who is on low dose tacrolimus maintenance therapy will be eligible provided the tacrolimus is withheld at least 1 week prior to transplant
Key Trial Info
Start Date :
August 17 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2018
Estimated Enrollment :
281 Patients enrolled
Trial Details
Trial ID
NCT00933231
Start Date
August 17 2009
End Date
April 3 2018
Last Update
November 1 2024
Active Locations (13)
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1
Site CA133 Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
2
Site CA54 University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
3
Site CA141 Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
4
Site CA114 Capital District Health Authority- QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7