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Belatacept to Prevent Organ Rejection in Kidney Transplant Patients (BESTT)

2017년 3월 23일 업데이트: National Institute of Allergy and Infectious Diseases (NIAID)

The Safety and Efficacy of Belatacept, Antithymocyte Globulin, and Sirolimus in Recipients of Non-HLA-identical Living-donor Renal Transplants (ITN023ST)

Belatacept is an experimental medication shown in clinical trials to have immune system suppression properties in people who have had renal (e.g., kidney) transplants. This study will determine whether a combination of anti-rejection drugs, including belatacept, can prevent the rejection of a first-time, non-human leukocyte antigen (HLA) identical renal transplant and allow patients to be safely withdrawn from anti-rejection therapy one year post-transplant.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

Drugs that suppress the immune system have contributed to increased success of transplantation; however, to prevent organ rejection, transplant recipients need to take immunosuppressive drugs for the rest of their lives. These drugs make patients more susceptible to infection and certain kinds of cancer. Belatacept is an experimental medication that specifically targets immune reactions against transplanted organs and has been shown to be effective in preventing kidney transplant rejection in previous clinical trials. Both thymoglobulin, an antibody, and sirolimus, an anti-rejection drug, prevent rejection by lowering the response of the immune system to the transplanted organ. This study will evaluate whether belatacept, along with thymoglobulin and sirolimus, is safe in kidney transplant patients. The study will also evaluate this regimen's potential to allow tapering and eventual discontinuation of all immunosuppressive drugs.

This study will last up to 4 years. At the time of transplant, participants will begin an immunosuppressive treatment regimen consisting of thymoglobulin, sirolimus, and belatacept. Participants will receive infusions of thymoglobulin on days 1 through 4, and a combination of oral sirolimus (daily) and belatacept infusions at day 5, then weeks 2, 4, 8, and monthly for at least 2 years. Dose reduction of belatacept will occur at 12 weeks post-transplant. At Year 2, eligible participants may choose to begin drug withdrawal or continue study therapy through the end of the study. Study visits will occur weekly for the first two months, then monthly. These visits will include belatacept treatment, general medical assessments, blood and urine collection, and other assessments to determine overall health of the recipient's immune system and kidney transplant and to better understand the way the immune system works in the acceptance or rejection of organ transplants.

*** IMPORTANT NOTICE: *** The National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network do not recommend the discontinuation of immunosuppressive therapy for recipients of cell, organ, or tissue transplants outside of physician-directed, controlled clinical studies. Discontinuation of prescribed immunosuppressive therapy can result in serious health consequences and should only be performed in certain rare circumstances, upon the recommendation and with the guidance of your health care provider.

연구 유형

중재적

등록 (실제)

5

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • California
      • San Francisco, California, 미국, 94143
        • University of California, San Francisco
    • Georgia
      • Atlanta, Georgia, 미국, 30322
        • Emory University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Receiving first renal (e.g., kidney) transplant
  • Transplant is from a non-HLA-identical living donor
  • Willing to use acceptable forms of contraception

Exclusion Criteria:

  • Positive for anti-human globulin (AHG) or T-cell cross-match with the donor
  • Receiving multiple-organ transplant
  • History of cancer within the 5 years prior to study entry. Patients who have certain nonmelanoma skin cancers are not excluded
  • Human immunodeficiency virus (HIV) infected
  • Hepatitis B (HBV) or C (HCV) virus infected
  • Other active infections
  • Active tuberculosis (TB) infection within the 3 years prior to study entry
  • Pregnancy or breastfeeding

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Belatacept
Immunosuppressive protocol consisting of belatacept, glucocorticoids, antithymocyte globulin (ATG), and sirolimus.
의약품: Belatacept
10 mg/kg given intravenously (IV) on transplant (day 1), day 5, and at weeks 2, 4, 8 and 12, then 5 mg/kg IV every 4 weeks
다른 이름들:
  • 누로직스
  • LEA29Y
의약품: Sirolimus
4 mg/day (oral tablet) at transplant (day 1), then dose adjusted to maintain serum trough level of 8-12 ng/mL for at least 1 year
다른 이름들:
  • 라파마이신
  • 라파뮨
의약품: Anti-thymocyte globulin
1.5 mg/kg given IV daily on days 1 through 4. Subjects are premedicated with glucocorticoids, acetaminophen 650 mg by mouth, and diphenhydramine 25- 50 mg by mouth prior to each dose.
다른 이름들:
  • ATG
  • 티모글로불린®
  • 항흉선세포 면역글로불린
의약품: methylprednisolone
500 mg given IV at transplant (day 1), then given 250 mg IV on day 2 and given 0.5 mg/kg IV or prednisone 0.5 mg/kg given by mouth on days 3 and 4
다른 이름들:
  • 메드롤
  • 글루코코르티코이드

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Acute Rejection at 6-Months
기간: 6 months post-transplant

Cumulative incidence of acute rejection[1] at 6 months post-transplant based on local pathology biopsy reads

  1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
6 months post-transplant

2차 결과 측정

결과 측정
측정값 설명
기간
Participant Survival at 12 Months Post-Transplant
기간: 12 months post-transplant
12 months post-transplant
Acute Rejection at 12-Months
기간: 12 months post-transplant

Incidence of acute rejection[1] at 12 months post-transplant

  1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
12 months post-transplant
Tolerance Induction
기간: 48 months
Time from transplantation to initiation of sirolimus withdrawal.
48 months
Renal Function as Measured by Glomerular Filtration Rate (GFR) at 24 Weeks
기간: 24 weeks post-transplant

GFR utilizing clearance of iothalamate.

GFR is an index of level of kidney function. A higher value means better kidney function.
24 weeks post-transplant
Graft Survival at 12 Months Post-transplant
기간: 12 months post-transplant
12 months post-transplant
Time From Transplant to Acute Rejection
기간: Transplantation until rejection occurs (participants followed up to four years post-transplantation)

Time (days) from transplant to occurrence of acute rejection[1]

  1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Transplantation until rejection occurs (participants followed up to four years post-transplantation)
Proportion of Participants Requiring Antilymphocyte Therapy for Acute Rejection
기간: Participants followed from transplantation until completion of study (up to four years post-transplantation)

Proportion of participants who experienced acute rejection[1] requiring antilymphocyte therapy

  1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With Post-transplant Infections
기간: Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of participants who experienced infections post-transplant. Participants were checked for any type of opportunistic infection at all study visits post-transplantation (up to 4 years post-transplantation)
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With Wound Complications
기간: Start of study to end of study
Start of study to end of study
Proportion of Participants With Malignancies
기간: Participants followed from transplantation until completion of study (up to four years post-transplantation)
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With a Sirolimus Associated Adverse Event
기간: Participants followed from transplantation until completion of study (up to four years post-transplantation)
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With Chronic Allograft Nephropathy
기간: Participants followed from transplantation until completion of study (up to four years post-transplantation)
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With Delayed Graft Function
기간: Participants followed from transplantation until completion of study (up to four years post-transplantation)
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With Post-transplant Diabetes Mellitus
기간: Participants followed from transplantation until completion of study (up to four years post-transplantation)
Participants followed from transplantation until completion of study (up to four years post-transplantation)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Institute of Allergy and Infectious Diseases (NIAID)

협력자

Immune Tolerance Network (ITN)

수사관

  • 수석 연구원: Flavio Vincenti, MD, University of California, San Francisco
  • 수석 연구원: Christian Larsen, MD, Emory University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2006년 12월 1일

기본 완료 (실제)

2010년 2월 1일

연구 완료 (실제)

2010년 2월 1일

연구 등록 날짜

최초 제출

2006년 6월 27일

QC 기준을 충족하는 최초 제출

2006년 6월 27일

처음 게시됨 (추정)

2006년 6월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 4월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 3월 23일

마지막으로 확인됨

2017년 3월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • DAIT ITN023ST

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Data access is provided to the public in Participant level data and additional relevant materials are available to the public in : 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools available to researchers; and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal that makes data from the consortium's clinical trials publicly available.

연구 데이터/문서

  1. 개별 참가자 데이터 세트
    정보 식별자: SDY674
    정보 댓글: ImmPort study identifier is SDY674
  2. 연구 프로토콜
    정보 식별자: SDY674
    정보 댓글: ImmPort study identifier is SDY674. The study protocol is available in the Design tab section.
  3. Study summary, -design, -synopsis,- medications, -demographics, -lab tests, -files
    정보 식별자: SDY674
    정보 댓글: ImmPort study identifier is SDY674
  4. 개별 참가자 데이터 세트
    정보 식별자: ITN023ST
    정보 댓글: TrialShare is a clinical trials research portal developed by the Immune Tolerance Network (ITN) that makes data from the consortium's clinical trials publicly available.
  5. Protocol synopsis, -data and reports, -specimens availability
    정보 식별자: ITN023ST
    정보 댓글: TrialShare is a clinical trials research portal developed by the Immune Tolerance Network (ITN) that makes data from the consortium's clinical trials publicly available.

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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