- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02780726
A Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia
2019년 12월 19일 업데이트: Astellas Pharma Inc
A Phase 3, Multi-center, Open-label Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia
The objective of this study is to evaluate the safety and efficacy of ASP1517 in peritoneal dialysis chronic kidney disease patients with anemia.
연구 개요
연구 유형
중재적
등록 (실제)
56
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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Aichi, 일본
- Site JP00002
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Aichi, 일본
- Site JP00004
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Aichi, 일본
- Site JP00010
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Aichi, 일본
- Site JP00013
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Fukuoka, 일본
- Site JP00001
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Fukuoka, 일본
- Site JP00005
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Hokkaido, 일본
- Site JP00012
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Hokkaido, 일본
- Site JP00014
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Ishikawa, 일본
- Site JP00006
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Kanagawa, 일본
- Site JP00008
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Nagano, 일본
- Site JP00003
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Okayama, 일본
- Site JP00015
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Osaka, 일본
- Site JP00009
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Tokushima, 일본
- Site JP00007
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Toyama, 일본
- Site JP00011
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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
20년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Female subject must either:
Be of non-childbearing potential:
- post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
- documented surgically sterile Or, if of childbearing potential,
- Agree not to try to become pregnant during the study and for 28 days after the final study drug administration
- And have a negative pregnancy test at Screening
And, if heterosexually active, agree to consistently use two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and continued for 28 days after the final study drug administration.
- Female subject must agree not to breastfeed starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration.
- Female subject must not donate ova starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration.
- Male subject and their female spouse/partners who are of childbearing potential must be using two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 12 weeks after the final study drug administration
- Male subject must not donate sperm starting at Screening and throughout the study period and, for 12 weeks after the final study drug administration
- Subjects who have not received Erythropoieses Stimulating Agents (ESAs):
- Subjects who have been receiving peritoneal dialysis for more than 4 weeks before the screening assessment
- Subjects who have never received ESAs after starting peritoneal dialysis, or subjects who have not received ESAs within 6 weeks before the screening assessment.
- Mean of the subject's two most recent Hb values before randomization during the Screening Period must be <10.5 g/dL with an absolute difference ≤1.3 g/dL between the two values
Either transferrin saturation (TSAT) ≥ 5% or serum ferritin ≥ 30 ng/mL during the screening period
- Subjects who have been receiving ESAs:
- Subjects with renal anemia who have been receiving ESA within the doses approved in Japan for more than 8 weeks after starting peritoneal dialysis, before the screening assessment
- Mean of the subject's two most recent Hb values before randomization during the Screening Period must be ≥10.0 g/dL and ≤12.0 g/dL
- TSAT ≥ 20% or serum ferritin ≥ 100 ng/mL during the screening period
Exclusion Criteria:
- Subjects who had trouble with continuing peritoneal dialysis due to peritonitis, development of catheter trouble (e.g. tunnel infection) within 4 weeks before the screening assessment
- Concurrent retinal neovascular lesion requiring treatment and macular edema requiring treatment
- Concurrent autoimmune disease with inflammation that could impact erythropoiesis
- History of gastric/intestinal resection considered influential on the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent gastro-paresis
- Uncontrolled hypertension
- Concurrent congestive heart failure (NYHA Class III or higher)
- History of hospitalization for treatment of stroke, myocardial infarction, or pulmonary embolism within 12 weeks before the screening assessment
- Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibody at the screening assessment, or positive for human immunodeficiency virus (HIV) in a past test
- Concurrent other form of anemia than renal anemia
- Having received treatment with protein anabolic hormone, testosterone enanthate, or mepitiostane within 6 weeks before the screening assessment
- Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), total bilirubin, or Alkaline Phosphatase (ALP) that is greater than the criteria below, or previous or concurrent another serious liver disease at screening assessment
- Previous or current malignant tumor (no recurrence for at least 5 years is eligible.)
- Having undergone blood transfusion and/or a surgical procedure considered to promote anemia (excluding shunt reconstruction surgery for access to the blood) within 4 weeks before the screening assessment
- Having undergone a kidney transplantation
- Having a previous history of treatment with ASP1517
- History of serious drug allergy including anaphylactic shock
- Participation in another clinical study or post-marketing clinical study (including that of a medical device) within 12 weeks before informed consent acquisition
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: ASP1517 Low Dose Group (ESA Untreated)
This group includes subjects who have not received Erythropoieses Stimulating Agents (ESAs).
Study drug will be dosed three times weekly and dose adjustments will be made during the study.
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경구
다른 이름들:
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실험적: ASP1517 High Dose Group (ESA Untreated)
This group includes subjects who have not received ESAs.
Study drug will be dosed three times weekly and dose adjustments will be made during the study.
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경구
다른 이름들:
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실험적: ASP1517 ESAs Treated Group
This group includes subjects who have received ESAs.
The treatment was converted from ESAs to study drug.
Study drug will be dosed three times weekly and dose adjustments will be made during the study.
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경구
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Hemoglobin (Hb) Response Rate from Week 18 to Week 24
기간: Up to Week 24
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Hb response defined as average Hb within the target range in this outcome
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Up to Week 24
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Hb Response rate
기간: Up to Week 24
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Hb response is defined as reaching target values for Hb and change of Hb from baseline in this outcome.
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Up to Week 24
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Average Hb levels from week 18 to week 24
기간: Up to week 24
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Up to week 24
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Change from baseline in the average Hb levels of week 18 to week 24
기간: Baseline and up to Week 24
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Baseline and up to Week 24
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Rate of rise in Hb levels (g/dL/week)
기간: Up to Week 4
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Up to Week 4
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Proportion of time points with target Hb levels
기간: Up to Week 24
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Up to Week 24
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Proportion of participants who achieve the target Hb level at each week
기간: Up to Week 24
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Up to Week 24
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Proportion of participants who achieve the lower limit of the target Hb level
기간: Up to Week 24
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Up to Week 24
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목표 Hb 수준의 하한에 도달하는 시간
기간: 24주까지
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24주까지
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Change from baseline in Hb level at each week
기간: Baseline and Up to Week 24
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Baseline and Up to Week 24
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Efficacy assessed by hematocrit
기간: Up to Week 24
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Hematocrit will be summarized by ASP1517 low dose Erythropoieses Stimulating Agent (ESA) untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
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Up to Week 24
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Efficacy assessed by reticulocytes/ erythrocytes
기간: Up to Week 24
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Reticulocytes/Erythrocytes will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
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Up to Week 24
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Efficacy assessed by Iron (Fe)
기간: Up to Week 24
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Fe will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
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Up to Week 24
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Efficacy assessed by ferritin
기간: Up to Week 24
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Ferritin will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
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Up to Week 24
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Efficacy assessed by transferrin
기간: Up to Week 24
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Transferrin will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
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Up to Week 24
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Efficacy assessed by total iron binding capacity
기간: Up to Week 24
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Total iron binding capacity will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
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Up to Week 24
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Efficacy assessed by soluble transferrin receptor
기간: Up to Week 24
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Soluble transferrin receptor will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
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Up to Week 24
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Efficacy assessed by transferrin saturation
기간: Up to Week 24
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Transferrin saturation will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
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Up to Week 24
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Efficacy assessed by reticulocyte hemoglobin content
기간: Up to Week 24
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Reticulocyte hemoglobin content will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
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Up to Week 24
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SF-36으로 평가한 삶의 질
기간: 24주까지
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SF-36: 의학적 결과 연구 36개 항목 약식 건강 조사
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24주까지
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Quality of life assessed by EQ-5D
기간: Up to Week 24
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EQ-5D: EuroQol 5 Dimension
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Up to Week 24
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FACT-An이 평가한 삶의 질
기간: 24주까지
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FACT-An: 암 치료의 기능적 평가-빈혈
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24주까지
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Occurrence of hospitalizations
기간: Up to Week 24
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Up to Week 24
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부작용 발생률로 안전성 평가
기간: 24주까지
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24주까지
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비정상적인 활력 징후 및/또는 치료와 관련된 부작용이 있는 참가자 수
기간: 24주까지
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24주까지
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표준 12-리드 심전도에 의해 평가된 안전성
기간: 24주까지
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24주까지
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비정상적인 실험실 값 및/또는 치료와 관련된 부작용이 있는 참가자 수
기간: 24주까지
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24주까지
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변경되지 않은 ASP1517의 혈장 농도
기간: 24주까지
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24주까지
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 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 (실제)
2016년 6월 22일
기본 완료 (실제)
2017년 8월 2일
연구 완료 (실제)
2017년 8월 2일
연구 등록 날짜
최초 제출
2016년 5월 20일
QC 기준을 충족하는 최초 제출
2016년 5월 20일
처음 게시됨 (추정)
2016년 5월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 12월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 12월 19일
마지막으로 확인됨
2019년 12월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 1517-CL-0302
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development.
Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared.
Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD 공유 기간
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD 공유 액세스 기준
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data.
The research proposal is reviewed by an Independent Research Panel.
If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD 공유 지원 정보 유형
- 연구 프로토콜
- 통계 분석 계획(SAP)
- 임상 연구 보고서(CSR)
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. .