Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation
NCT ID: NCT01046955
Last Updated: 2010-01-12
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
38 participants
INTERVENTIONAL
2005-11-30
2008-12-31
Brief Summary
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Detailed Description
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To determine the effect different antibody induction regimen on the lymphoid cell subsets of the immune system in kidney allograft recipients peripheral blood and bone marrow aspirates will be tested at surgery before transplantation and at intervals post operatively.
To treat renal transplant patients successfully in the absence of long-term calcineurin inhibition to determine if there are beneficial effects on the prevention of chronic allograft nephropathy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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1mg/kg Thymoglobulin
LD kidneys receiving 1mg/kg Thymoglobulin for 7 days starting at the day of surgery.
Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab
comparison of induction therapies.
Campath-1H at 0.3 mg/kg
Recipients of LD kidneys receiving Campath-1H at 0.3 mg/kg once on the day of surgery and again 3 days post-operatively.
Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab
comparison of induction therapies.
Zenapax 1 mg/kg
Recipients of LD kidneys receiving Zenapax 1mg/kg on the day of surgery followed by the same dose every 2 weeks for a total of 5 dosages.
Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab
comparison of induction therapies.
Interventions
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Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab
comparison of induction therapies.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weight \>40 kg
* Primary renal allograft:living related (non HLA identical) and unrelated donor
* Negative standard cross match for T-cells
* Signed and dated consent form
Exclusion Criteria
* Patient has received a kidney transplant from a non-heart beating donor
* Patient has received an ABO incompatible donor kidney
* Recipient or donor is seropositive for human immunodeficiency virus (HIV)
* Patient has a current malignancy or a history of malignancy
14 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
University of Miami
OTHER
Responsible Party
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University of Miami
Principal Investigators
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George W Burke, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami Jackson Memorial Hospital
Miami, Florida, United States
Countries
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Other Identifiers
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20010704
Identifier Type: -
Identifier Source: org_study_id
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