Alefacept in Kidney Transplant Recipients
This study has been withdrawn prior to enrollment.
(The drug will no longer be available in the United States.)
Sponsor:
University Hospital Case Medical Center
Collaborator:
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
Donald Hricik, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01433770
First received: September 8, 2011
Last updated: February 17, 2012
Last verified: February 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Kidney Transplantation |
Drug: Amevive |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Effects of Alefacept on Donor-Specific Memory in Kidney Transplant Recipients |
Resource links provided by NLM:
Further study details as provided by University Hospital Case Medical Center:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The incidence of clinically overt infections will be descriptive or calculated as a simple percentage. [ Time Frame: 12, 24, and 36 months ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Alefacept action on memory T cells |
Drug: Amevive
Alefacept 15mg subcutaneous; once a week for 12 weeks
Other Name: Alefacept
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433770
Locations
| United States, Ohio | |
| University Hospitals Case Medical Center | |
| Cleveland, Ohio, United States, 44106 | |
Sponsors and Collaborators
University Hospital Case Medical Center
Astellas Pharma Global Development, Inc.
Investigators
| Principal Investigator: | Donald E Hricik, MD | University Hospital Case Medical Center |
More Information
No publications provided
| Responsible Party: | Donald Hricik, Professor of Medicine, Chief Division of Nephrology and Hypertension, Medical Director Transplantation Services, University Hospital Case Medical Center |
| ClinicalTrials.gov Identifier: | NCT01433770 History of Changes |
| Other Study ID Numbers: | 02-11-06 |
| Study First Received: | September 8, 2011 |
| Last Updated: | February 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Alefacept Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013