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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Geneva、スイス
- Geneva University Hospitals
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Lausanne、スイス
- Centre Hospitalier Universitaire Vaudois
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター：コントロールアーム
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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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実験的：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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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microalbuminuria excretion rate (spot or 24h)
時間枠：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
時間枠：Baseline; 1 week + 24 weeks after treatment start
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Baseline; 1 week + 24 weeks after treatment start
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Filtration fraction %
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Antoinette Pechère、University Hospital, Geneva
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 09-136
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Placeboの臨床試験
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