- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00378014
Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy
2015년 1월 19일 업데이트: Novartis Pharmaceuticals
Presentation of Renal Function in Liver Transplant Recipients With Certican Therapy: PROTECT Study A Twelve-month, Multicenter, Randomized, Open-label Study of Safety, Tolerability and Efficacy of Certican-based Regimen Versus Calcineurin Inhibitor-based Regimen in de Novo Liver Transplant Recipients
The study is designed to show that everolimus initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as compared to continuation of CNI-based treatment.
연구 개요
연구 유형
중재적
등록 (실제)
276
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Groningen, 네덜란드, 9713 GZ
- Novartis Investigative Site
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Rotterdam, 네덜란드, 3015 CE
- Novartis Investigative Site
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Berlin, 독일, 13353
- Novartis Investigative Site
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Essen, 독일, 45147
- Novartis Investigative Site
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Frankfurt, 독일, 60590
- Novartis Investigative Site
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Hamburg, 독일, 20246
- Novartis Investigative Site
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Hannover, 독일, 30625
- Novartis Investigative Site
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Heidelberg, 독일, 69120
- Novartis Investigative Site
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Jena, 독일, 07740
- Novartis Investigative Site
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Muenster, 독일, 48149
- Novartis Investigative Site
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Regensburg, 독일, 93053
- Novartis Investigative Site
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Tübingen, 독일, 72076
- Novartis Investigative Site
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Genève, 스위스, 1211
- Novartis Investigative Site
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Zurich, 스위스, 8091
- Novartis Investigative Site
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Innsbruck, 오스트리아, A-6020
- Novartis Investigative Site
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Wien, 오스트리아, A-1090
- Novartis Investigative Site
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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:
- Males or females 18 - 70 years old
- Liver transplant recipient (living or deceased donor)
- Patients in whom an allograft biopsy will not be contraindicated
Exclusion Criteria:
- Recipients of multiple solid organ transplants or patients that have already received a transplant in the past
- HCV positive patients who need an active anti-viral treatment (HCV- positive patients without active antiviral treatment are allowed)
- HIV positive patients
- Patients who are breast feeding
- Patients with a current severe systemic infection
- Presence of any hypersensitivity to drugs similar to Certican® (e.g. macrolides)
- Preexisting (i.e. not related to CNI-damage) renal dysfunction that, according to the judgment of the investigator, will not significantly improve after transplantation (i.e., for example, patients that are expected to have a cGFR below 50ml/min at 4 weeks post transplantation)
- Patients that have received Simulect prior to this study.
- Other protocol-defined inclusion/exclusion criteria may apply.
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: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Everolimus
Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
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All patients who met the eligibility criteria were treated with 2 doses of basiliximab on Day 0 (transplantation) and Day 4.
다른 이름들:
Patients who met the screening eligibility received CNI-based immunosuppressive therapy for 1 month.
Then at week 4 (or week 8 at maximum), patients randomized to the CNI arm continued on CNI-based immunosuppressive therapy.
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활성 비교기: Calcineurin Inhibitor (CNI)
Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
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All patients who met the eligibility criteria were treated with 2 doses of basiliximab on Day 0 (transplantation) and Day 4.
다른 이름들:
Patients who met the screening eligibility received CNI-based immunosuppressive therapy for 1 month.
Then at week 4 (or week 8 at maximum), patients randomized to the CNI arm continued on CNI-based immunosuppressive therapy.
Start dose of everolimus was 1.5 mg in the morning followed by 1.5 mg in the evening.
After one week, the dose was adjusted to achieve trough levels between 5-12 ng/mL.
Once trough levels were above 5ng/mL, the CNI dose was reduced to 70%.
At week 8 post-baseline (latest at week 16 post baseline), CNI was completely discontinued.
For patients receiving Ciclosporin A (CiA) as CNI, the everolimus dosage was adjusted to achieve a trough level of 8-12 ng/mL, prior to discontinuation of CiA.
After discontinuation of CNI, everolimus was maintained at a trough level of 5-12 ng/mL.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Calculated Glomerular Filtration Rate (cGFR)
기간: Month 11
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This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.
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Month 11
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Incidence of Efficacy Failure
기간: Month 11
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Efficacy failure was defined as the composite endpoint of biopsy-proven acute rejection (BPAR), graft loss, death, lost to follow-up (from any reason), whichever occurred first.
Incidence of efficacy failure was estimated using crude rate estimation (relative frequency).
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Month 11
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Incidence of the Need for a Change in the Immunosuppressive Regimen
기간: Month 11
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The incidence of any changes in the immunosuppressive regimen other than allowed in the study protocol (for example, introduction of Mycophenolic acid (MPA) or sirolimus) was estimated using crude rate estimation (relative frequency).
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Month 11
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Incidence of Renal Deterioration
기간: Baseline, Month 11
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Renal deterioration was defined as a decrease by ≥25% in the cGFR compared to baseline and confirmed by one consecutive measurement.
The analysis of this outcome measure was omitted because of missing relevance.
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Baseline, Month 11
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Renal Function (cGFR)
기간: Month 5
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This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.
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Month 5
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Incidence of Treated BPAR
기간: Month 11
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The incidence of treated BPAR was estimated using crude rate estimation (relative frequency).
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Month 11
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Patient and Graft Survival
기간: Month 11
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Patient survival was defined as the time from date of randomization to date of death from any cause.
If a patient was not known to have died, patient survival was censored as the date of last contact.
Graft survival was defined as the time from the date of randomization to the date of graft loss.
If a patient was not known to suffer from a graft loss or died without graft loss, time to graft loss was censored with date of last contact or date of death, respectively.
Patient and graft survival were analyzed using the Kaplan Meier method.
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Month 11
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Hepatitis C Virus (HCV) Replication in HCV-positive Patients
기간: Baseline, Month 5
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HCV ribonucleic acid (RNA) was measured by real time reverse transcriptase polymerase chain reaction (PCR; copies per mL).
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Baseline, Month 5
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Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
기간: From randomization to Month 11
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Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.
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From randomization to Month 11
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Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
기간: Month 12 to Month 59 post-baseline
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Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.
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Month 12 to Month 59 post-baseline
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 8월 1일
기본 완료 (실제)
2013년 1월 1일
연구 완료 (실제)
2013년 1월 1일
연구 등록 날짜
최초 제출
2006년 9월 15일
QC 기준을 충족하는 최초 제출
2006년 9월 18일
처음 게시됨 (추정)
2006년 9월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 2월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 1월 19일
마지막으로 확인됨
2015년 1월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CRAD001HDE10
- 2005-002920-32
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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