Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
2017년 3월 1일 업데이트: KAI Pharmaceuticals
A Double-Blind, Randomized, Placebo-Controlled Multiple Ascending Dose Study to Assess the Safety, Tolerability and Efficacy of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism
The purpose of this study is to characterize the safety and tolerability and efficacy of multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of secondary hyperparathyroidism (HPT).
연구 개요
연구 유형
중재적
등록 (실제)
87
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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Azusa, California, 미국, 91702
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Costa Mesa, California, 미국, 92626
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Lynwood, California, 미국, 90262
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Riverside, California, 미국, 92505
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San Diego, California, 미국, 92123
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Colorado
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Denver, Colorado, 미국, 80218
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Georgia
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Macon, Georgia, 미국, 31217
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Louisiana
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Shreveport, Louisiana, 미국, 71101
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Minnesota
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Brooklyn Center, Minnesota, 미국, 55430
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19106
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Texas
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Houston, Texas, 미국, 77004
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Houston, Texas, 미국, 77099
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Virginia
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Chesapeake, Virginia, 미국, 23320
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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 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Subject provides written informed consent.
- Intact parathyroid hormone (PTH) at least 350 pg/mL.
- Corrected calcium at least 9.0 mg/dL.
- Hemoglobin at least 9.0 g/dL.
- Adequate hemodialysis three times per week.
- Excepting chronic renal failure, subject is judged to be in stable medical condition based on medical history, physical examination, and routine laboratory tests.
Exclusion Criteria:
- History or symptomatic ventricular dysrhythmias.
- History of angina pectoris or congestive heart failure
- History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months.
- History of or treatment for seizure disorder.
- Recent (3 months) parathyroidectomy.
- Serum transaminases (alanine aminotransferase, aspartate aminotransferase) greater than two times the upper limit of normal at screening.
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: 순차적 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Etelcalcetide
Participants received etelcalcetide administered by intravenous injection at the end of each hemodialysis session three times a week (TIW).
The starting dose level was 5 mg; dose escalation was to proceed to 10 and 20 mg pending safety review of the prior cohort.
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Administered intravenously (IV) at the end of hemodialysis
다른 이름들:
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위약 비교기: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW).
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Administered intravenously at the end of hemodialysis
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percent Change From Baseline in Mean Pre-hemodialysis Parathyroid Hormone (PTH) During the Efficacy Assessment Phase
기간: Baseline and the efficacy assessment phase (EAP; defined as the period between 3 days before and 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1.
The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
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Baseline and the efficacy assessment phase (EAP; defined as the period between 3 days before and 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants With ≥ 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase
기간: Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1.
The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
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Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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Percentage of Participants With Mean Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase
기간: Efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
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Efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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Percent Change From Baseline in Mean Corrected Calcium (cCa) During the Efficacy Assessment Phase
기간: Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1.
The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
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Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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Percent Change From Baseline in Mean Phosphorus (P) During the Efficacy Assessment Phase
기간: Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1.
The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
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Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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Percent Change From Baseline in Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase
기간: Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
|
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1.
The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
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Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
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Percentage of Participants With Mean Phosphorus ≤ 4.5 mg/dL or ≤ 5.5 mg/dL During the Efficacy Assessment Phase
기간: Efficacy assessment phase
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Efficacy assessment phase
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: M D, Amgen
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
2011년 2월 20일
기본 완료 (실제)
2011년 7월 1일
연구 완료 (실제)
2011년 8월 24일
연구 등록 날짜
최초 제출
2010년 12월 3일
QC 기준을 충족하는 최초 제출
2010년 12월 3일
처음 게시됨 (추정)
2010년 12월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 4월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 3월 1일
마지막으로 확인됨
2017년 3월 1일
추가 정보
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. .
속발성 부갑상선기능항진증에 대한 임상 시험
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Nordsjaellands HospitalHvidovre University Hospital; Nordstar Medical아직 모집하지 않음