Alefacept in Kidney Transplant Recipients

NCT ID: NCT01433770

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-10-31

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.

Conditions

Kidney Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Alefacept action on memory T cells

Group Type: EXPERIMENTAL

Amevive

Intervention Type: DRUG

Alefacept 15mg subcutaneous; once a week for 12 weeks

Interventions

Amevive

Alefacept 15mg subcutaneous; once a week for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Alefacept

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Global Development, Inc.

INDUSTRY

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Donald Hricik

Professor of Medicine, Chief Division of Nephrology and Hypertension, Medical Director Transplantation Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donald E Hricik, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

02-11-06

Identifier Type: -

Identifier Source: org_study_id