- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
-
Geneva, Suisse
- Geneva University Hospitals
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Lausanne, Suisse
- Centre Hospitalier Universitaire Vaudois
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Bras de commande
|
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
|
Expérimental: 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
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
microalbuminuria excretion rate (spot or 24h)
Délai: Baseline; 1 week + 24 weeks after treatment start
|
Baseline; 1 week + 24 weeks after treatment start
|
eGFR
Délai: Baseline; 1 week + 24 weeks after treatment start
|
Baseline; 1 week + 24 weeks after treatment start
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Filtration fraction %
Délai: Baseline; 1 week + 24 weeks after treatment start
|
Baseline; 1 week + 24 weeks after treatment start
|
|
24h Ambulatory Blood Pressure
Délai: 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
Délai: Baseline; 1 week and 48 weeks after treatment start
|
Baseline; 1 week and 48 weeks after treatment start
|
|
Adverse Events
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Antoinette Pechère, University Hospital, Geneva
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 09-136
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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