- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01714440
Genomics of Kidney Transplantation
연구 개요
상세 설명
In the past, the major problems in kidney transplantation were surgical complications, acute rejection, and infections. Right now, researchers are focusing on improving immune suppression therapy and achieving better long-term survival of kidney transplants. One of the ways to try to understand what causes loss of function after many years is to find out if there is a genetic factor involved.
There are a number of differences in specific genes that have been identified and are thought to affect transplant outcomes. Studying these gene variations (differences between people or differences between populations) is important in determining whether these variations are related to transplant outcomes and how this information can help patients achieve better long-term transplant survival.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama
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Minnesota
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Minneapolis, Minnesota, 미국, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, 미국, 55414
- University of Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic
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Alberta
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Edmonton, Alberta, 캐나다, T6G 2B7
- University of Alberta
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Kidney (or kidney-pancreas) transplant recipient no more than 10 days post-transplant or kidney donor no more than 30 days post-transplant or previously enrolled in Phase I of the Genomics of Kidney Transplantation Study;
- No organs other than kidney or pancreas transplanted simultaneously with the qualifying kidney transplant; and
- Participant or parent/guardian must be able to understand and provide written informed consent.
Inclusion for the Activity and mRNA Expression Cohort:
- Recipient enrolled in the Main Cohort Study;
- Informed consent for participation in the Activity and mRNA Expression Cohort;
- Age 18 years or greater as of day of transplantation;and
- Will receive tacrolimus, cyclosporine or mycophenolate as part of maintenance immunosuppression therapy.
Exclusion Criteria:
- Inability or unwillingness of the participant or parent/guardian to give a written informed consent or comply with the study protocol.
For the Activity and mRNA Expression Cohort:
- Inability or unwillingness of the participant or parent/guardian to give a written informed consent for participation in the Activity and mRNA Expression Cohort or comply with the study protocol.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Transplant Recipients Cohort
Main Study Cohort: Kidney (or kidney-pancreas) transplant recipients.
Enrollment for this cohort is closed.
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Transplant Donors Cohort
Main Study Cohort: The kidney donor for transplant recipients in this study.
Enrollment for this cohort is closed.
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Activity&mRNA Expression Substudy Cohort
A subset of subjects enrolled in the main study who will receive tacrolimus, cyclosporine or mycophenolate as part of maintenance immunosuppression therapy.
This group has a prospective observational cohort design.
Enrollment into the Activity and messenger ribonucleic acid (mRNA) Expression Cohort, occurring concurrently with enrollment of the rest of the study, will continue until either the required sample size of 600 is achieved or the protocol team terminates enrollment.
Participants in the Activity and mRNA Expression Cohort have additional blood draws up to 2 weeks prior to transplant, at week 1, Month 3 and Month 6 post-transplant.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Transplant recipient genotypes: time to chronic graft disfunction
기간: Day 0 to Year 5
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Day 0 to Year 5
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Transplant recipient genotypes: time to a persistent 25% decrease in Estimated Glomerular Filtration Rate (eGFR)
기간: Day 0 to Year 5
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eGFR: Estimated GFR test results are a measure of kidney function.
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Day 0 to Year 5
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Transplant recipient genotypes: time to acute rejection
기간: Day 0 to Year 5
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Day 0 to Year 5
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Transplant recipient genotypes: time to allograft failure
기간: Day 0 to Year 5
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allograft failure is defined as graft loss or participant death.
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Day 0 to Year 5
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Donor Genotypes: time to chronic graft dysfunction
기간: Day 0 to Year 5
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The time to dysfunction of the donated organ.
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Day 0 to Year 5
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Donor Genotypes: time to a persistent 25% decrease in eGFR
기간: Day 0 to year 5
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The time to a persistent 25% decrease in eGFR in the donated organ's recipient.
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Day 0 to year 5
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Donor Genotypes: time to allograft failure
기간: Day 0 to Year 5
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The time to the failure of the donated organ (defined as graft loss or participant death).
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Day 0 to Year 5
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Recipient genotypes: time to select mycophenolate-related toxicities (leukopenia, anemia)
기간: Day 0 to Year 5
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Day 0 to Year 5
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Recipient genotypes: time to select Calcineurin Inhibitor (CNI)-related toxicities
기간: Day 0 to Year 5
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Toxicities may include: new onset diabetes or nephrotoxicity.
CNI: calcineurin inhibitor
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Day 0 to Year 5
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Recipient genotypes: repeated measures of clinically obtained tacrolimus trough blood levels
기간: Day 0 to Year 5
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Day 0 to Year 5
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Recipient candidate genotypes: Calcineurin (CN) and IMPDH protein activity and expression
기간: Day 0 to Year 5
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CN: Calcineurin.
IMPDH: Inosine-5'-monophosphate dehydrogenase
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Day 0 to Year 5
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time to composite endpoint of graft loss or death or persistent 25% increase in serum creatinine
기간: Day 0 to Year 5
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Day 0 to Year 5
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Time to renal biopsy with presence of the following semi-quantitative pathology endpoints: patterns of Banff biopsy score, presence of circulating anti-donor anti-Human Leukocyte Antigen (HLA) antibodies, C4d positivity
기간: Day 0 to Year 5
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Day 0 to Year 5
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Slope of eGFR
기간: Day 0 to Year 5
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Day 0 to Year 5
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Delayed graft function
기간: Day 0 to Year 5
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Day 0 to Year 5
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Time to Epstein-Barr virus (EBV) and Cytomegalovirus (CMV) infection
기간: Day 0 to Year 5
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EBV: Epstein-Barr virus.
CMV: cytomegalovirus.
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Day 0 to Year 5
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공동 작업자 및 조사자
수사관
- 수석 연구원: A Matas, MD, University of Minnesota
- 연구 의자: A Israni, MD, MS, University of Minnesota
간행물 및 유용한 링크
일반 간행물
- Oetting WS, Schladt DP, Dorr CR, Wu B, Guan W, Remmel RP, Ikle D, Mannon RB, Matas AJ, Israni AK, Jacobson PA; DeKAF Genomics and GEN03 Investigators. Analysis of 75 Candidate SNPs Associated With Acute Rejection in Kidney Transplant Recipients: Validation of rs2910164 in MicroRNA MIR146A. Transplantation. 2019 Aug;103(8):1591-1602. doi: 10.1097/TP.0000000000002659.
- Nguyen TT, Pearson RA, Mohamed ME, Schladt DP, Berglund D, Rivers Z, Skaar DJ, Wu B, Guan W, van Setten J, Keating BJ, Dorr C, Remmel RP, Matas AJ, Mannon RB, Israni AK, Oetting WS, Jacobson PA. Pharmacogenomics in kidney transplant recipients and potential for integration into practice. J Clin Pharm Ther. 2020 Dec;45(6):1457-1465. doi: 10.1111/jcpt.13223. Epub 2020 Jul 14.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- DAIT GEN-03
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신장 이식 기증자에 대한 임상 시험
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Baylor College of MedicinePatient-Centered Outcomes Research Institute; M.D. Anderson Cancer Center; The University... 그리고 다른 협력자들완전한말기 심부전 | BTT(Bridge-to-Transplant LVAD 배치) | 목적지 치료 LVAD 배치(DT) | LVAD 배치 거부(거절자) | LVAD 간병인미국