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

March 29, 2010
January 24, 2013
April 2010
December 2016   (final data collection date for primary outcome measure)
  • 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 ]
  • Albuminuria Excretion Rate [ Time Frame: Baseline; 1 week + 48 weeks after treatment start ] [ Designated as safety issue: No ]
  • Filtration Fraction [ Time Frame: Baseline; 1 week + 48 weeks after treatment start ] [ Designated as safety issue: No ]
  • Vessel Vasodilatation [ Time Frame: Baseline; 1 week + 48 weeks after treatment start ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01095939 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Glomerular Filtration Rate [ Time Frame: Baseline; 1 week + 48 weeks after treatment start ] [ Designated as safety issue: No ]
  • 24h Ambulatory Blood Pressure [ Time Frame: Baseline; 1 week and 48 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 ]
Not Provided
Not Provided
 
Post-preeclampsia Renal Project: Study of Nephroprotection in Women Having Suffered Preeclampsia
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Renal Alteration
  • 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
  • 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
  • Placebo Comparator: Control Arm
    Intervention: Drug: Placebo
  • Experimental: Benazepril
    Intervention: Drug: Benazepril hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
June 2017
December 2016   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Antoinette Pechère, MD +41223729598 antoinette.pechere@hcuge.ch
Contact: Jocelyne Chabert, PhD +4179 55 32 217 jocelyne.chabert@hcuge.ch
Switzerland
 
NCT01095939
09-136
No
Antoinette Pechere-Bertschi, MD, University Hospital, Geneva
University Hospital, Geneva
Not Provided
Principal Investigator: Antoinette Pechère University Hospital, Geneva
University Hospital, Geneva
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP