- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01095939
Post-preeclampsia Renal Project: Study of Nephroprotection in Women Having Suffered Preeclampsia (RPPEC)
A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Benazepril (ATC N° C09AA07) in the Treatment of Persistent Renal Dysfunction in Pre-eclamptic Women
연구 개요
상세 설명
Several epidemiological studies suggest that the risk of death from cardiovascular causes among women with preeclampsia may be increased, and that preeclampsia contrary to what has been long thought, is not cured with delivery. Preeclampsia has long been considered a 2-stage disease, stage one corresponding to an impaired placental perfusion resulting from abnormal spiral artery remodeling, and stage two corresponding to the maternal manifestations of disease, characterized by hypertension and proteinuria. However, preeclampsia might include an additional, 3rd stage, that of the post-partum period (Gammill & Roberts, 2007) This phase deserves to be investigated. In particular, it is crucial to determine whether the changes that occur in renal hemodynamics during preeclampsia are reversible after more than 6 weeks, and whether PEC women are salt-sensitive after delivery.
The link between chronic kidney disease and cardiovascular mortality is well established. An independent, graded association exists between a reduced GFR and the risk of death, cardiovascular events, and hospitalization (Go et al, 2004). Besides, salt-sensitivity is associated with an increased cardiovascular and renal risk (Franco & Oparil, 2006). The Renal Post PEC study aims at establishing if the renal dysfunctions that occur in PEC women can be reversed by the administration of inhibitors of the renin-angiotensin system that are known to improve cardiovascular and renal risk profiles in hypertensive patients. By virtue of their potent renal vasodilatory properties and favourable remodelling of the GBM, ACE inhibitors may improve salt-sensitivity, endothelial function, renal plasma flow and GFR, and general renal prognosis in women who experienced from preeclampsia.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Geneva, 스위스
- Geneva University Hospitals
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Lausanne, 스위스
- Centre Hospitalier Universitaire Vaudois
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Pre-selection Criteria:
- Normotensive women with no proteinuria before the 20th week of gestation AND
- Women with hypertension (BP ≥140/90 mm Hg) and proteinuria (≥ 0.3 g /24h or 2++ dipstick) after the 20th week of gestation
Inclusion Criteria:
- Clearance of creatinine ≤ 80 ml/min (Gault et Cockcroft)
- Serum creatinine ≥ 80 µmol/L
- Microalbuminuria comprised between 30 and 300 mg/d and/or a urinary spot with microalbuminuria/creatinine ratio ≥ 3.5 and/or macroalbuminuria (24h urinary albumin excretion ≥ 0.500 mg)
- BP ≥ 140/90 mm Hg OR ongoing antihypertensive treatment
- CRP ≥ 4 mg/dL
Exclusion Criteria:
- Those unlikely to co-operate in the study
- Those who refuse to use appropriate contraceptive measures during the treatment period (intrauterine device, oral contraceptives, condom, diaphragm)
- Those with a history of pre-term delivery
- Those with known history of severe allergic reaction
- Those who consume drugs
- Aged < 18 years old
공부 계획
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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위약 비교기: 컨트롤 암
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Tablets; oral administration; once a day for 6 months.
After this period of 6 months blinded treatment, the treatment will be stopped for 2 weeks.
At the end of this washout period, a new renal evaluation is done.
At that time, opened label treatment will be proposed to the women who still show renal alterations after a 2 weeks washout period
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실험적: Benazepril
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Tablets (10 or 20 mg); oral administration; once a day for 6 months.
After this period of 6 months blinded treatment, the treatment will be stopped for 2 weeks.
At the end of this washout period, a new renal evaluation is done.
At that time, opened label treatment will be proposed to the women who still show renal alterations after a 2 weeks washout period
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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microalbuminuria excretion rate (spot or 24h)
기간: Baseline; 1 week + 24 weeks after treatment start
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Baseline; 1 week + 24 weeks after treatment start
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eGFR
기간: Baseline; 1 week + 24 weeks after treatment start
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Baseline; 1 week + 24 weeks after treatment start
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Filtration fraction %
기간: Baseline; 1 week + 24 weeks after treatment start
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Baseline; 1 week + 24 weeks after treatment start
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24h Ambulatory Blood Pressure
기간: Baseline; 1 week and 24 weeks after treatment start
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Mean; diurnal; nocturnal
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Baseline; 1 week and 24 weeks after treatment start
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Effective Renal Plasma Flow
기간: Baseline; 1 week and 48 weeks after treatment start
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Baseline; 1 week and 48 weeks after treatment start
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Adverse Events
기간: From signature of informed consent until last follow-up visit (36 months after treatment start)
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From signature of informed consent until last follow-up visit (36 months after treatment start)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Antoinette Pechère, University Hospital, Geneva
간행물 및 유용한 링크
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 09-136
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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Placebo에 대한 임상 시험
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AJU Pharm Co., Ltd.OM Pharma SA모병
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University Hospital, Strasbourg, France모집하지 않고 적극적으로