Status:
WITHDRAWN
Alefacept in Kidney Transplant Recipients
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Astellas Pharma Global Development, Inc.
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Alefacept, also known as Amevive®, is a medication approved by the Food and Drug Administration (FDA) in the United States and other countries for the treatment of psoriasis, which is a chronic inflam...
Eligibility Criteria
Inclusion
- Able and willing to sign informed consent
- Adult (\>18years) kidney-alone transplant recipient
- 6 months post-transplant
- Persistently positive donor-stimulated ELISPOT-IFN (≥30 spots/300K cells)-2 positive assays separated by at least one week
- Female subjects of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment and must agree to maintain effective birth control during the study
Exclusion
- Baseline CD4 count \<250 cells/uL
- Acute rejection episode within the 3 months prior to enrollment
- Clinically overt infection within the 3 months prior to enrollment
- History of BK polyoma viremia
- Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
- Subject has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
- Any major illnesses/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study, or could preclude the evaluation of the subject's response
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01433770
Start Date
October 1 2011
End Date
October 1 2014
Last Update
February 22 2012
Active Locations (1)
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1
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106