A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients
NCT ID: NCT00617604
Last Updated: 2016-02-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
218 participants
INTERVENTIONAL
2007-12-31
2009-09-30
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
PREVENTION
QUADRUPLE
Study Groups
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Placebo
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
placebo
IV and subcutaneous injection
Tacrolimus
The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery.
Mycophenolate Mofetil
Mycophenolic mofetil was administered as 750 mg twice per day orally
Steroids
Methylprednisolone or equivalent:
Day 0: 500 - 1000 mg IV bolus Day 1: 125 - 250 mg IV bolus
Prednisone or equivalent:
Days 2 - 14: 20 - 30 mg orally Days 15 - 28: 10 - 20 mg orally Days 29 - 60: 10 - 15 mg orally Days 61 onwards: 5 - 10 mg orally
Alefacept
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Alefacept
IV and subcutaneous injection
Tacrolimus
The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery.
Mycophenolate Mofetil
Mycophenolic mofetil was administered as 750 mg twice per day orally
Steroids
Methylprednisolone or equivalent:
Day 0: 500 - 1000 mg IV bolus Day 1: 125 - 250 mg IV bolus
Prednisone or equivalent:
Days 2 - 14: 20 - 30 mg orally Days 15 - 28: 10 - 20 mg orally Days 29 - 60: 10 - 15 mg orally Days 61 onwards: 5 - 10 mg orally
Interventions
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Alefacept
IV and subcutaneous injection
placebo
IV and subcutaneous injection
Tacrolimus
The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery.
Mycophenolate Mofetil
Mycophenolic mofetil was administered as 750 mg twice per day orally
Steroids
Methylprednisolone or equivalent:
Day 0: 500 - 1000 mg IV bolus Day 1: 125 - 250 mg IV bolus
Prednisone or equivalent:
Days 2 - 14: 20 - 30 mg orally Days 15 - 28: 10 - 20 mg orally Days 29 - 60: 10 - 15 mg orally Days 61 onwards: 5 - 10 mg orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female subject at least 18 years of age and younger than 65 years
* Subject receiving a kidney transplant from a non-human leucocyte antigen (HLA) identical living donor or deceased HLA identical/non-HLA identical donor between 5 and 59 years of age with compatible ABO blood type (Blood group system A, B, AB and 0)
Exclusion Criteria
* Subject received a kidney transplant from a non-heart beating donor
* Subject has received a kidney transplant from a 50 - 59 year old donor with two of the following three factors: history of hypertension, cerebrovascular accident as cause of death, final pre-procurement serum creatinine \> 1.5 mg/dL (united network for organ sharing \[UNOS\] expanded criteria donor)
* Cold ischemia time of the donor kidney is ≥ 30 hours
18 Years
64 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Central Contact
Role: STUDY_CHAIR
Astellas Pharma Europe B.V.
Locations
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Vienna, , Austria
Brussels, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Liège, , Belgium
Prague, , Czechia
Créteil, , France
Le Kremlin-Bicêtre, , France
Montpellier, , France
Nantes, , France
Nice, , France
Paris, , France
Toulouse, , France
Bochum, , Germany
Regensburg, , Germany
Budapest, , Hungary
Bologna, , Italy
Padua, , Italy
Rome, , Italy
Siena, , Italy
Maastricht, , Netherlands
Bydgoszcz, , Poland
Poznan, , Poland
Szczecin, , Poland
Barcelona, , Spain
Llobregat, , Spain
Madrid, , Spain
Málaga, , Spain
Santander, , Spain
Gothenburg, , Sweden
Uppsala, , Sweden
Manchester, , United Kingdom
Countries
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Other Identifiers
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2007-002092-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
0485-CL-E201
Identifier Type: -
Identifier Source: org_study_id
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