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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Geneva
Sponsor:
Information provided by (Responsible Party):
Antoinette Pechere-Bertschi, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01095939
First received: March 29, 2010
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Renal Alteration
Drug: Placebo
Drug: Benazepril hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • microalbuminuria excretion rate (spot or 24h) [ Time Frame: Baseline; 1 week + 24 weeks after treatment start ] [ Designated as safety issue: No ]
  • eGFR [ Time Frame: Baseline; 1 week + 24 weeks after treatment start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Filtration fraction % [ Time Frame: Baseline; 1 week + 24 weeks after treatment start ] [ Designated as safety issue: No ]
  • 24h Ambulatory Blood Pressure [ Time Frame: Baseline; 1 week and 24 weeks after treatment start ] [ Designated as safety issue: No ]
    Mean; diurnal; nocturnal

  • Effective Renal Plasma Flow [ Time Frame: Baseline; 1 week and 48 weeks after treatment start ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: From signature of informed consent until last follow-up visit (36 months after treatment start) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: April 2010
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: placebo
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095939

Contacts
Contact: Antoinette Pechère, MD +41223729598 antoinette.pechere@hcuge.ch
Contact: Jocelyne Chabert, PhD +4179 55 32 217 jocelyne.chabert@hcuge.ch

Locations
Switzerland
Geneva University Hospitals Recruiting
Geneva, Switzerland
Contact: Antoinette Pechère, MD    +41 22 372 95 98    antoinette.pechere@hcuge.ch   
Principal Investigator: Antoinette Pechère, MD         
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Switzerland
Contact: Michel Burnier, MD    +41 21 692 50 08    michel.burnier@chuv.ch   
Contact: Gregoire Wuerzner    +41 21 314 11 14    Gregoire.wuerzner@chuv.ch   
Principal Investigator: Michel Burnier, MD         
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Antoinette Pechère University Hospital, Geneva
  More Information

No publications provided

Responsible Party: Antoinette Pechere-Bertschi, MD, Dr, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01095939     History of Changes
Other Study ID Numbers: 09-136
Study First Received: March 29, 2010
Last Updated: January 24, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
Renal function consecutive to pre-eclampsia

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Benazepril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014