Alefacept in Kidney Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01433770
Recruitment Status : Withdrawn (The drug will no longer be available in the United States.)
First Posted : September 14, 2011
Last Update Posted : February 22, 2012
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
Donald Hricik, University Hospital Case Medical Center

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 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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Amevive Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effects of Alefacept on Donor-Specific Memory in Kidney Transplant Recipients
Study Start Date : October 2011
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Alefacept action on memory T cells Drug: Amevive
Alefacept 15mg subcutaneous; once a week for 12 weeks
Other Name: Alefacept

Primary Outcome Measures :
  1. Absolute changes in ELISPOTS, PRT (Panel Reactive T Cells), and lymphocyte subsets will be analyzed using paired t-tests to compare baseline vs 4, 8, 12, 16, and 24 weeks of follow-up [ Time Frame: 12, 24, and 36 months ]

Secondary Outcome Measures :
  1. The incidence of clinically overt infections will be descriptive or calculated as a simple percentage. [ Time Frame: 12, 24, and 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01433770

United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Astellas Pharma Global Development, Inc.
Principal Investigator: Donald E Hricik, MD University Hospitals Cleveland Medical Center

Responsible Party: Donald Hricik, Professor of Medicine, Chief Division of Nephrology and Hypertension, Medical Director Transplantation Services, University Hospital Case Medical Center Identifier: NCT01433770     History of Changes
Other Study ID Numbers: 02-11-06
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Dermatologic Agents