Alefacept in Kidney Transplant Recipients

Effects of Alefacept on Donor-Specific Memory in Kidney Transplant Recipients

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.

Study Overview

• Status: Withdrawn
• Conditions: Kidney Transplantation
• Intervention / Treatment: Drug: Amevive

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	12, 24, and 36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence of clinically overt infections will be descriptive or calculated as a simple percentage.	12, 24, and 36 months

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Astellas Pharma Global Development, Inc.
• Investigators: Principal Investigator: Donald E Hricik, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): October 1, 2013
• Study Completion (Anticipated): October 1, 2014

Study Registration Dates

• First Submitted: September 8, 2011
• First Submitted That Met QC Criteria: September 12, 2011
• First Posted (Estimate): September 14, 2011

Study Record Updates

• Last Update Posted (Estimate): February 22, 2012
• Last Update Submitted That Met QC Criteria: February 17, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Dermatologic Agents; Alefacept
• Other Study ID Numbers: 02-11-06