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.
연구 개요
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ohio
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Cleveland, Ohio, 미국, 44106
- University Hospitals Case Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Alefacept action on memory T cells
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Alefacept 15mg subcutaneous; once a week for 12 weeks
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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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
기간: 12, 24, and 36 months
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12, 24, and 36 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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The incidence of clinically overt infections will be descriptive or calculated as a simple percentage.
기간: 12, 24, and 36 months
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12, 24, and 36 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Donald E Hricik, MD, University Hospitals Cleveland Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 02-11-06
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