Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection
NCT ID: NCT00885820
Last Updated: 2014-09-18
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
PHASE4
240 participants
INTERVENTIONAL
2001-09-30
2006-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Protocol biopsies at 1, 2 and 3 months
Tacrolimus
Oral
MMF
Oral
Corticosteroids (Prednisone)
Oral
2
No protocol biopsies
Tacrolimus
Oral
MMF
Oral
Corticosteroids (Prednisone)
Oral
Interventions
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Tacrolimus
Oral
MMF
Oral
Corticosteroids (Prednisone)
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods
Exclusion Criteria
* Recipient of non-related donor kidney with peak pre-transplant PRA \> 50
* Subject has lost a previous graft to rejection less than one year from transplant
* Subject who has received an investigational drug within three months prior to randomization
* Subjects who are pregnant or breastfeeding
* Subject receives a kidney lacking a pre-implantation biopsy
* Subject has significant disease or disability (e.g. malignancy or uncontrolled infection) which prevents adherence to the protocol
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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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Canada, Inc.
Locations
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Palo Alto, California, United States
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Countries
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References
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Rush DN, Cockfield SM, Nickerson PW, Arlen DJ, Boucher A, Busque S, Girardin CE, Knoll GA, Lachance JG, Landsberg DN, Shapiro RJ, Shoker A, Yilmaz S. Factors associated with progression of interstitial fibrosis in renal transplant patients receiving tacrolimus and mycophenolate mofetil. Transplantation. 2009 Oct 15;88(7):897-903. doi: 10.1097/TP.0b013e3181b723f4.
Other Identifiers
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FKC-008
Identifier Type: -
Identifier Source: org_study_id
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