Status:
COMPLETED
A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
De Novo Kidney Transplantation
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy ...
Eligibility Criteria
Inclusion
- Subject with end stage kidney disease who is a suitable candidate for primary kidney transplantation or retransplantation
- 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
- Subject has a panel reactivity antibody grade \> 20% in the previous 6 months and/or had had a previous graft survival shorter than 1 year due to immunological reasons
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT00617604
Start Date
December 1 2007
End Date
September 1 2009
Last Update
February 4 2016
Active Locations (33)
Enter a location and click search to find clinical trials sorted by distance.
1
Vienna, Austria, 1090
2
Brussels, Belgium, 1070
3
Brussels, Belgium, 1200
4
Ghent, Belgium, 9000