Queen's University Investigation of Calcification in Chronic Kidney Disease (QUICK)
The Use of Bisphosphonates to Prevent or Delay the Progression of Vascular Calcification in End-Stage Renal Disease: A Randomized Controlled Trial
Kidney disease is a fundamental part of medicine because of its prominence in Western society. Common conditions such as diabetes, hypertension and kidney infections can all progress to End-Stage Renal Disease (ESRD) also known as Stage 5 chronic kidney disease (CKD 5). Once ESRD has begun, kidney function is poor at best, thus the body is unable to effectively clear harmful toxins from the blood.
A common feature of ESRD is vascular calcification, a process where blood vessels (especially arteries) attract deposits of the mineral calcium. Over time, these deposits harden and thicken in the layers of blood vessels, which limit blood flow to body tissues and can produce significant disease including hypertension, heart disease and stroke. Although the process of vascular calcification is unknown, there is mounting evidence that it is mediated by cellular events that are similar to those seen in bone formation with in the body (osteogenesis). With this point in mind, it has been suggested that agents medicine employs to limit excess bone formation will reduce the rate of vascular calcification in CKD Stage 5.
This study will employ one group of drugs called bisphosphonates which have been used to limit bone formation. It will study their effect on vascular calcification in adult dialysis patients.
연구 개요
상세 설명
Presently, there exist few therapies aimed at retarding the progression of vascular calcification. One study showed that agents that limit the absorption of phosphate from food (phosphate binders) slow the progression of vascular calcification, and as a result, treatments emphasize phosphate control through diet and phosphate binders. Other studies have shown that the use of statins, to lower LDL cholesterol levels may reduce the progression of coronary calcification in non-ESRD patients, but data from ESRD are lacking. While these treatments have been helpful, the improvements in patients' outcomes have not been overwhelming positive.
This proposed study is not the first to study the use of bisphosphonates on vascular calcification. Repeated studies have shown impressive reduction in calcification rates in several animal models, which begs the question, how will bisphosphonates fare in human subjects? Preliminary research has begun, but clearly an expansive trial on humans is needed to explore the use of a promising therapy. Our study hopes to provide insight into this area of cardiovascular research.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Ontario
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Kingston, Ontario, 캐나다, K7L 2V7
- Kingston General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18 years of age
- receiving maintenance renal replacement therapy for less than 12 months
- incident patients starting renal replacement therapy for the first time
Exclusion Criteria:
- active vasculitis
- severe hypocalcemia
- previous adverse side effect to bisphosphonate use
- current use of corticosteroids
- weight greater than 300 pounds
- pregnancy
- not expected to survive greater than one year
- expected to discontinue renal replacement therapy during the study period or recover renal function
- evidence of adynamic bone disease
- current bisphosphonate use
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 1
Arm #1 will include patients randomized to receive bisphosphonate therapy for 24 months.
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35mg given orally once weekly for 24 months
다른 이름들:
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위약 비교기: 2
Arm #2 will include patients randomized to receive placebo therapy for 24 months
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identical placebo pill once weekly for 24 months
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Absolute change in coronary artery calcification score (CaSc) from baseline to study completion.
기간: 24 months
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24 months
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2차 결과 측정
결과 측정 |
기간 |
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Change in bone density score (wrist/hip) as calculated by Ct scanning method, # fractures, MI, Stroke, amputation/surgery for peripheral revascularization.
기간: 24 months
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24 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Karen E Yeates, Dr, Queen's University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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 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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