Endothelin Receptor Antagonism in Proteinuric Nephropathy
The Systemic & Renal Effects of Endothelin Receptor Antagonism in Proteinuric Nephropathy
연구 개요
상태
상세 설명
Response to ETA Receptor Antagonism/Nifedipine/Placebo Prior to the study visit subjects will be asked to refrain from alcohol for 24 hours. Tea and coffee will not be permitted for at least 12 hours before each visit. Studies will be conducted in a quiet, temperature-controlled room.
On arrival at the Clinical Research Centre on the study day, a brief medical enquiry and examination will confirm the ongoing suitability of the subject for the study. An intravenous cannula will be inserted into the antecubital fossa of each arm. We have developed a basic protocol described fully in our previous studies that allows us to measure systemic haemodynamics by the well validated technique of bioimpedance and renal function by standard para-aminohippurate (PAH; renal blood flow) and inulin (glomerular filtration rate) clearance studies.
Urinary protein excretion will be measured by collecting urine over 30 minute time periods. To ascertain the contribution of renal haemodynamics to any change in protein excretion renal blood flow and glomerular filtration rate will be measured. In addition, blood and urine will also be assayed for sodium, creatinine and osmolality to allow calculation of fractional excretion of sodium and free water clearance.
Systemic haemodynamic monitoring will be performed at 15 minute intervals during drug/placebo administration and at 30 minute intervals outwith these periods.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Scotland
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Edinburgh, Scotland, 영국, EH4 2XU
- Clinical Research Centre, Western General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female
- Age 18-70
- Body mass index <35
- Blood pressure <160/110 mmHg
- CKD stage 2-5 as per the K/DOQI classification
- Proteinuria in one of the following categories: 0.3-1.5, >1.5-3.0, and >3.0-6.0 g/24hrs
- Normal serum albumin
Exclusion Criteria:
- Subject is below the age of legal consent, or is mentally or legally incapacitated
- History of multiple and/or severe allergic reactions to drugs (including study drugs), or food
- The subject has donated blood (450 ml) within the last 4 weeks
- Past or present drug or alcohol abuse including intravenous drug abuse at any time
- Participation in another clinical trial within 1 month
- Considered to be at high risk of HIV or hepatitis B
- Pregnant
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 1
Placebo control arm of study
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Single 15ml 0.9% saline infused for 15 mins as placebo control
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실험적: 2
BQ-123 arm of study
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Single dose of BQ-123 given at a dose of 1000 nmol/min for 15 min intravenously.
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활성 비교기: 3
Nifedipine arm of study
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Single dose of nifedipine 10 mg given orally as active control
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Proteinuria
기간: Acute change in proteinuria over 4 hour period following BQ-123 dosing
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Acute change in proteinuria over 4 hour period following BQ-123 dosing
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Blood pressure
기간: Acute change in blood pressure over 4 hour period following BQ-123 dosing
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Acute change in blood pressure over 4 hour period following BQ-123 dosing
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2차 결과 측정
결과 측정 |
기간 |
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Arterial stiffness (as measured by pulse wave velocity)
기간: Acute change in arterial stiffness over 4 hour period following BQ-123 dosing
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Acute change in arterial stiffness over 4 hour period following BQ-123 dosing
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Endothelial function (as measured by flow-mediated dilatation)
기간: Acute change in endothelial function over 4 hour period following BQ-123 dosing
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Acute change in endothelial function over 4 hour period following BQ-123 dosing
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공동 작업자 및 조사자
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2006/WCRC/02
- PG/05/91
- 06/MRE00/12
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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