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
NCT ID: NCT00933231
Last Updated: 2024-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
281 participants
INTERVENTIONAL
2009-08-17
2018-04-03
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Tacrolimus Standard Dose with ACEi/ARB
Participants receive a standard dose of tacrolimus with ACEi/ARB.
tacrolimus
Standard dose, Oral
Simulect
IV
Cellcept
Oral
Corticosteroids
IV and Oral
Ramipril
Oral
Irbesartan
Oral
Tacrolimus Standard Dose without ACEi/ARB
Participants receive a standard dose of tacrolimus without ACEi/ARB.
tacrolimus
Standard dose, Oral
Simulect
IV
Cellcept
Oral
Corticosteroids
IV and Oral
Tacrolimus Low Dose with ACEi/ARB
Participants receive a low dose of tacrolimus with ACEi/ARB.
tacrolimus
Low dose, Oral
Simulect
IV
Cellcept
Oral
Corticosteroids
IV and Oral
Ramipril
Oral
Irbesartan
Oral
Tacrolimus Low Dose without ACEi/ARB
Participants receive a low dose of tacrolimus without ACEi/ARB.
tacrolimus
Low dose, Oral
Simulect
IV
Cellcept
Oral
Corticosteroids
IV and Oral
Interventions
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tacrolimus
Standard dose, Oral
tacrolimus
Low dose, Oral
Simulect
IV
Cellcept
Oral
Corticosteroids
IV and Oral
Ramipril
Oral
Irbesartan
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Astellas Pharma Canada, Inc.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Principal Investigator
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Canada, Inc.
Locations
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Site CA133 Foothills Medical Centre
Calgary, Alberta, Canada
Site CA54 University of Alberta Hospital
Edmonton, Alberta, Canada
Site CA141 Health Sciences Centre
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
Site CA64 Centre Hospitalier Universitaire de Québec- L'Hôtel-dieu de Québec
Québec, Quebec, Canada
Site CA116 Centre Hospitalier Universitaire de Sherbrooke- Hôpital Fleuirmont
Sherbrooke, Quebec, Canada
Site CA142 St. Paul's Hospital
Saskatoon, Saskatchewan, Canada
Countries
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References
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Campbell PM, Cantarovich M, Gangji A, Houde I, Jevnikar AM, Monroy-Cuadros FM, Nickerson PW, Paquet MR, Prasad GVR, Senecal L, Wolff JL, Schwartz JJ, Rush DN. A Five-Year Prospective, Randomized, Open-Label Study of Standard-Dose Versus Low-Dose Prolonged-Release Tacrolimus With or Without Angiotensin-Converting Enzyme Inhibitor or Angiotensin II Receptor Blocker Post Kidney Transplantation. Clin Transplant. 2025 Jan;39(1):e70067. doi: 10.1111/ctr.70067.
Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.
Cockfield SM, Wilson S, Campbell PM, Cantarovich M, Gangji A, Houde I, Jevnikar AM, Keough-Ryan TM, Monroy-Cuadros FM, Nickerson PW, Paquet MR, Ramesh Prasad GV, Senecal L, Shoker A, Wolff JL, Howell J, Schwartz JJ, Rush DN. Comparison of the effects of standard vs low-dose prolonged-release tacrolimus with or without ACEi/ARB on the histology and function of renal allografts. Am J Transplant. 2019 Jun;19(6):1730-1744. doi: 10.1111/ajt.15225. Epub 2019 Feb 1.
Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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FKC-014
Identifier Type: -
Identifier Source: org_study_id
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