Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant
2015년 6월 30일 업데이트: Veloxis Pharmaceuticals
Ph 2 Double-blind, Double-dummy, Multicenter, Prospective, Rand Study of PK of LCP-Tacro™ Tablets Once Daily, Compared to Prograf® Caps, Twice Daily, for Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients
The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.
연구 개요
상세 설명
This is a 2-arm , parallel group, prospective, double-blind, double-dummy, multicenter,clinical trial to evaluate the pharmacokinetics of LCP-Tacro tablets once daily in comparison to Prograf capsules twice-daily after kidney transplantation.
연구 유형
중재적
등록 (실제)
36
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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San Diego, California, 미국, 92123
- Clinical Investigative Site 000015
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San Francisco, California, 미국, 94115
- Clinical Investigative Site 000012
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Colorado
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Aurora, Colorado, 미국, 80045
- Clinical Investigative Site 00004
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Florida
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Tampa, Florida, 미국, 33606
- Clinical Investigative Site 000002
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Kentucky
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Lexington, Kentucky, 미국, 40536-0293
- Clinical Investigative Site 000005
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- Clinical Investigative Site 000009
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New Jersey
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Livingston, New Jersey, 미국, 07039
- Clinical Investigative Site 000010
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New York
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Buffalo, New York, 미국, 14215
- Clinical Investigative Site 000011
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New York, New York, 미국, 10016
- Clinical Investigative Site 00006
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Ohio
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Cleveland, Ohio, 미국, 44095
- Clinical Investigative Site 00008
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Clinical Investigative Site 00003
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Texas
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Dallas, Texas, 미국, 75246
- Clinical Investigative Site 000013
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Virginia
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Charlottesville, Virginia, 미국, 22903
- Clinical Investigative Site 00001
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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
- Give written consent
- Male and female subjects between the ages of 18 and 70 years, inclusive
- Must be receiving primary or secondary renal allograft from a deceased donor or non- HLA identical living donor
- WOCBP must have a negative pregnancy test
- Must have negative cross-match test and be ABO-compatible
- Must be able to swallow tablets and capsules
Exclusion criteria
- Recipients of any previous nonrenal or concurrent transplant
- Have panel reactive antibody >50%
- Any condition that may affect study drug absorption BMI <18 kg/m2 or > 45 kg/m2
- History of alcohol abuse with less than 6 months of sobriety
- History of recreational drug abuse with less than 6 months of documented abstinence
- Screening 12-lead ECG demonstrating CS abnormalities (including QTc prolongation)
- WOCBP and are either pregnant, lactating, planning to become pregnant or with a positive serum or urine pregnancy test
- Subjects (male or female) with reproductive potential who are unwilling/unable to use a double-barrier method
- Oral temperature (prior to study drug dosing) of 38.0ºC or higher
- CS active infections (eg, those requiring hospitalization, or as judged by the Investigator)
- Known hereditary immunodeficiency
- Malignancies or with a history of malignancies (within the last 5 years) with the exception of local, noninvasive, fully excised cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ
- Expect to receive within 2 months after randomization, or have received within 3 months prior to screening, any of the following: sirolimus, everolimus, belatacept, or cyclophosphamide
- Any psychiatric or medical condition that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- Clinically symptomatic CHF or documented EJF of less than 45%
- Significant COPD, pulmonary restrictive disease or significant pulmonary hypertension
- Enrolled in another investigational drug or device study, or who are less than 30 days since discontinuing
- Laboratory variables that are abnormal (outside laboratory reference range) and CS
- Positive results of any of the following serological tests: human immunodeficiency virus (HIV)-1 antibody, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and anti-hepatitis C virus (HCV) antibody (HCV Ab)
- Subjects who have had primary focal segmental glomerulosclerosis
- Donor parameters must not include any of the following known conditions:
Donor with positive serological test result for HIV-1, HBV or HCV Donor with history of malignant disease (current or historical) Cold ischemia time >30 hours Non-heart-beating donor
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: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: LCP-Tacro
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
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Tacrolimus
다른 이름들:
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활성 비교기: Prograf
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
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Tacrolimus
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
기간: 1 days
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The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients.
Samples were collected from 0 to 24 hours post dose.
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1 days
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Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
기간: 14 days
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The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients.
Samples were collected from 0 to 24 hours post dose.
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14 days
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Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
기간: 28 days
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The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients.
Samples were collected from 0 to 24 hours post dose.
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28 days
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Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
기간: 1 days
|
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.
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1 days
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Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
기간: 14 days
|
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.
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14 days
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Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
기간: 28 days
|
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.
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28 days
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Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
기간: 1 days
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The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.
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1 days
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Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
기간: 14 days
|
The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.
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14 days
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Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
기간: 28 days
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The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.
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28 days
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Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
기간: 14 days
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The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.
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14 days
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Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
기간: 28 days
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The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.
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28 days
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.
기간: 14 days
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At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.
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14 days
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Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.
기간: 28 days
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At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Day 28.
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28 days
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Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.
기간: 14 days
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At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.
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14 days
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Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.
기간: 28 days
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At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 28.
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28 days
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Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.
기간: 30 days
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The efficacy is measured by the number of treatment failures defined as all-cause mortality, Graft Failure, Biopsy Proven Acute Rejection (BPAR) and Lost to follow up.
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30 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: William Polvino, MD, Veloxis Pharmaceuticals
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
2012년 11월 1일
기본 완료 (실제)
2013년 3월 1일
연구 완료 (실제)
2013년 5월 1일
연구 등록 날짜
최초 제출
2012년 8월 14일
QC 기준을 충족하는 최초 제출
2012년 8월 14일
처음 게시됨 (추정)
2012년 8월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 7월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 6월 30일
마지막으로 확인됨
2015년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- LCP-Tacro 2019
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