- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00133172
Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection
September 5, 2014 updated by: Astellas Pharma Inc
Evaluation of the Long-term Safety and Efficacy of a Tacrolimus-based 5-day Steroid Rapid Withdrawal Immunoprophylactic Regimen in de Novo Renal Transplantation
The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
85
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
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Edmonton, Alberta, Canada, T6G 2B7
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
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Vancouver, British Columbia, Canada, V5Z 1C6
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Ontario
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Hamilton, Ontario, Canada, L8N 4A6
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London, Ontario, Canada, N6A 5A5
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Ottawa, Ontario, Canada, K1H 7W9
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Toronto, Ontario, Canada, M5G 2N2
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Toronto, Ontario, Canada, M5C2T2
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
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Montreal, Quebec, Canada, H3A 1A1
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Montreal, Quebec, Canada, H2L 4M1
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Quebec City, Quebec, Canada, G1R 2J6
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7M 0Z9
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject or legally acceptable guardian has signed and dated a Research Ethics Board (REB)-approved informed consent form and is willing and able to follow study procedures.
- Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant.
- Subject is 18 years of age or over at the time of transplant.
- If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods
Exclusion Criteria:
- Recipients of a kidney from a donor 60 years of age or older
- Recipients of donation after cardiac death (DCD) donors
- Recipients of a combined transplant (e.g. kidney-pancreas, -lung, -heart)
- Subjects with a second renal allograft who had their original graft for < 2 years, unless the initial graft was lost in the early (1 year or less) post transplant course due to a technical or surgical failure
- Subjects with a current/latest pre-transplant panel of reactive antibodies (PRA) >20
- Subjects with hepatitis B & C, HIV or cancer (excluding successfully excised squamous or basal cell carcinoma)
- Subjects receiving an allograft with cold ischemia time 24 hours or greater
- Subjects who have received an investigational drug within three months prior to randomization
- Subjects who are breastfeeding
- Subjects with known hypersensitivity to tacrolimus, mycophenolate mofetil, methylprednisolone, basiliximab, prednisone, or any related drugs or their excipients
- Subjects with significant disease (e.g. uncontrolled infection) or disability (e.g. cognitive deficit) that prevents understanding of or adherence to the protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Steroid rapid 5-day withdrawal
|
IV
Other Names:
IV
Other Names:
IV
|
ACTIVE_COMPARATOR: 2
Standard steroid maintenance
|
IV
Other Names:
IV
Other Names:
IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Combined incidence of biopsy proven subclinical rejection (BPSCR) and biopsy proven clinical acute rejection (BPCAR)
Time Frame: 3 months post transplant
|
3 months post transplant
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biopsy proven chronic allograft nephropathy(CAN)
Time Frame: 2 years post transplant
|
2 years post transplant
|
Patient and graft survival rates
Time Frame: End of study (5 years)
|
End of study (5 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Medical Monitor, Astellas Pharma Canada, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (ACTUAL)
March 1, 2007
Study Completion (ACTUAL)
March 1, 2007
Study Registration Dates
First Submitted
August 22, 2005
First Submitted That Met QC Criteria
August 22, 2005
First Posted (ESTIMATE)
August 23, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
September 8, 2014
Last Update Submitted That Met QC Criteria
September 5, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Calcineurin Inhibitors
- Prednisone
- Tacrolimus
- Mycophenolic Acid
Other Study ID Numbers
- FKC-011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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