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Alefacept in Kidney Transplant Recipients

NCT01433770 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-02-22

No results posted yet for this study

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

Interventions

DRUG

Amevive

Alefacept 15mg subcutaneous; once a week for 12 weeks

Sponsors & Collaborators

  • Astellas Pharma Global Development, Inc.

    collaborator INDUSTRY

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Donald E Hricik, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01433770 on ClinicalTrials.gov