Alefacept in Kidney Transplant Recipients

NCT01433770 | Withdrawn

• 1 other identifier: 02-11-06
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (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

  12, 24, and 36 months

Secondary Outcomes (1)

• The incidence of clinically overt infections will be descriptive or calculated as a simple percentage.

  12, 24, and 36 months

Study Arms (1)

Alefacept action on memory T cells

EXPERIMENTAL

Drug: Amevive

Interventions

Amevive DRUG

Alefacept 15mg subcutaneous; once a week for 12 weeks

Also known as: Alefacept

Alefacept action on memory T cells

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to sign informed consent
• Adult (\>18years) kidney-alone transplant recipient
• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Astellas Pharma Global Development, Inc.: collaborator

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Interventions

Alefacept

Intervention Hierarchy (Ancestors)

CD58 Antigens; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Membrane Proteins; Recombinant Fusion Proteins; Recombinant Proteins

Study Officials

• Donald E Hricik, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Chief Division of Nephrology and Hypertension, Medical Director Transplantation Services

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: September 14, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2014
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

US (1)