Precision Medicine Offers Belatacept Monotherapy (PROBE)
Precision Medicine Offers Belatacept Monotherapy (PROBE)
연구 개요
상세 설명
Patients on belatacept who fulfill the entry criteria will be screened to determine if they have a quiescent molecular immunologic profile with kSORT and uCRM. Patients who screen negative on all 2 tests will undergo stepwise withdrawal first of steroids then of MMF or mTor inhibitors. Prior to each withdrawal the 2 screening molecular tests will be performed and advancement to the next withdrawal phase will be performed if both are negative. Patients who are maintained on belatacept monotherapy with quiescent kSORT and uCRM and elevated kSPOT will be transitioned to q 8 weeks belatacept administration.
Forty patients who are previously enrolled in belatacept based regimens with a minimum of 7 years of follow up at 4 transplant centers and who are maintained on belatacept, an antiproliferative ± steroids will be approached for enrollment.
Drug withdrawal of steroids (in patients on steroids) and of antiproliferatives (MPAs or mTor inhibitors) will follow the design shown in the Study Schema. Patients who continue to be stable for 3 months on belatacept monotherapy will be converted from q 4 weeks to q 8 weeks belatacept administrations.
연구 유형
단계
- 4단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Stable renal function with a GFR ≥ 35 ml/min
- No history of acute rejection
- A spot urine protein creatinine ratio of 0.5 or less
- No DSA
Entry: Biomarker criteria
- Blood kSORT and urine CRM tests that are quiescent at entry and following each drug withdrawal.
- A third biomarker KSPOT will be used to assess if any patients has achieved tolerance.
Eligibility for 8 week Belatacept Administration
- Trough levels of belatacept at 4 weeks of greater than 2 µg/ml
- Trough levels of belatacept at 8 weeks of equal or greater than 1 µg/ml
Exclusion Criteria:
- Patients with < eGFR (35 ml/min)
- History of rejection
- Protein/creatinine rate >0.5
- Presence of DSA
공부 계획
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 |
|---|---|
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실험적: Belatacept patients
Forty patients who are previously enrolled in belatacept based regimens with a minimum of 7 years of follow up at 4 transplant centers and who are maintained on belatacept, an antiproliferative ± steroids will be approached for enrollment. Drug withdrawal of steroids (in patients on steroids) and of antiproliferatives (MPAs or mTor inhibitors). Patients who continue to be stable for 3 months on belatacept monotherapy will be converted from q 4 weeks to q 8 weeks belatacept administrations. |
The transition to belatacept monotherapy and possibly to q 8 weeks administration can be safely done by applying personalized (i.e.
precision) medicine.
This includes phenotypic analysis of lymphocyte subsets, a quiescent molecular profiling of blood and urine prior to drug withdrawal and immune monitoring with KSORT after stepwise withdrawal of steroids and antiproliferatives.
Furthermore, trough PK of belatacept will be measured for conversion to q 8 week therapy for discovering research purposes.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percent patients converted to belatacept
기간: 12 months
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To determine the percent of patients that can be safely converted to belatacept monotherapy
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12 months
|
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Percent patients safely converted to q8 week administration
기간: 12 months
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2. To determine the percent of patients on belatacept monotherapy that can be safely converted to 8 week administration of belatacept
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12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Flavio Vincenti, MD, University of California, San Francisco
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
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
- IM103-382
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .
Belatacept에 대한 임상 시험
-
Nantes University Hospital알려지지 않은
-
Nantes University Hospital아직 모집하지 않음