Alefacept in Kidney Transplant Recipients

Withdrawn before enrolling · Not applicable

Conditions studied: Kidney Transplantation

In brief

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 inflammatory immunological skin condition that can result in chronic dry, red patches that are covered in scales. Alefacept is approved by the FDA for the treatment of psoriasis but not as an anti-rejection medication in transplant patients. It is now being tested in new kidney transplant patients as a supplement to other approved anti-rejection drugs. Alefacept will be used as an investigational drug in this study. The reason for this study is to test whether using Alefacept will inhibit T cells, known as memory cells, using a test named ELISPOT-IFN. In patients with psoriasis, Alefacept inhibits these memory cells. If memory cells specific to your donor can be inhibited by this drug, it might prevent rejection and promote acceptance of the transplanted kidney in a unique manner.

Key facts

Study ID

NCT01433770

Run by

University Hospitals Cleveland Medical Center

People needed

0

Starts

2011-10-01

Expected to finish

2014-10-01

Last updated by the study team

2012-02-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Hospitals Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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