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

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ClinicalTrials.gov Identifier: NCT01095939
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Antoinette Pechere-Bertschi, MD, University Hospital, Geneva

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Alteration Drug: Placebo Drug: Benazepril hydrochloride Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control Arm Drug: Placebo
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

Experimental: Benazepril Drug: Benazepril hydrochloride
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
Other Names:
  • Cibacen
  • Lotensin
  • ATC: C09AA07




Primary Outcome Measures :
  1. microalbuminuria excretion rate (spot or 24h) [ Time Frame: Baseline; 1 week + 24 weeks after treatment start ]
  2. eGFR [ Time Frame: Baseline; 1 week + 24 weeks after treatment start ]

Secondary Outcome Measures :
  1. Filtration fraction % [ Time Frame: Baseline; 1 week + 24 weeks after treatment start ]
  2. 24h Ambulatory Blood Pressure [ Time Frame: Baseline; 1 week and 24 weeks after treatment start ]
    Mean; diurnal; nocturnal

  3. Effective Renal Plasma Flow [ Time Frame: Baseline; 1 week and 48 weeks after treatment start ]
  4. Adverse Events [ Time Frame: From signature of informed consent until last follow-up visit (36 months after treatment start) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095939


Locations
Switzerland
Geneva University Hospitals
Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Antoinette Pechère University Hospital, Geneva

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Antoinette Pechere-Bertschi, MD, Dr, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01095939     History of Changes
Other Study ID Numbers: 09-136
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Keywords provided by Antoinette Pechere-Bertschi, MD, University Hospital, Geneva:
Renal function consecutive to pre-eclampsia

Additional relevant MeSH terms:
Benazepril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents