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Post-preeclampsia Renal Project: Study of Nephroprotection in Women Having Suffered Preeclampsia (RPPEC)

2018年4月30日 更新者:Antoinette Pechere-Bertschi, MD、University Hospital, Geneva

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

The purpose of the Post-preeclampsia Renal Project is to investigate the renal function of preeclamptic women after delivery, and to determine whether the anti-hypertensive drug named benazepril efficiently improves the dysfunctions observed.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

120

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Geneva、瑞士
        • Geneva University Hospitals
      • Lausanne、瑞士
        • Centre Hospitalier Universitaire Vaudois

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较:控制臂
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
实验性的:Benazepril
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
其他名称:
  • 洛汀新
  • Cibacen
  • ATC: C09AA07

研究衡量的是什么?

主要结果指标

结果测量
大体时间
microalbuminuria excretion rate (spot or 24h)
大体时间:Baseline; 1 week + 24 weeks after treatment start
Baseline; 1 week + 24 weeks after treatment start
eGFR
大体时间:Baseline; 1 week + 24 weeks after treatment start
Baseline; 1 week + 24 weeks after treatment start

次要结果测量

结果测量
措施说明
大体时间
Filtration fraction %
大体时间:Baseline; 1 week + 24 weeks after treatment start
Baseline; 1 week + 24 weeks after treatment start
24h Ambulatory Blood Pressure
大体时间:Baseline; 1 week and 24 weeks after treatment start
Mean; diurnal; nocturnal
Baseline; 1 week and 24 weeks after treatment start
Effective Renal Plasma Flow
大体时间:Baseline; 1 week and 48 weeks after treatment start
Baseline; 1 week and 48 weeks after treatment start
Adverse Events
大体时间:From signature of informed consent until last follow-up visit (36 months after treatment start)
From signature of informed consent until last follow-up visit (36 months after treatment start)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Antoinette Pechère、University Hospital, Geneva

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年4月1日

初级完成 (实际的)

2015年12月1日

研究完成 (实际的)

2018年3月1日

研究注册日期

首次提交

2010年3月29日

首先提交符合 QC 标准的

2010年3月29日

首次发布 (估计)

2010年3月30日

研究记录更新

最后更新发布 (实际的)

2018年5月1日

上次提交的符合 QC 标准的更新

2018年4月30日

最后验证

2018年4月1日

更多信息

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在美国制造并从美国出口的产品

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