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Clinical Trials/NCT01095939
NCT01095939CompletedPhase 3

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

University Hospital, Geneva2 sites in 1 country120 target enrollmentStarted: April 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
120
Locations
2
Primary Endpoint
microalbuminuria excretion rate (spot or 24h)

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Control Arm

Placebo Comparator

Intervention: Placebo (Drug)

Benazepril

Experimental

Intervention: Benazepril hydrochloride (Drug)

Outcomes

Primary Outcomes

microalbuminuria excretion rate (spot or 24h)

Time Frame: Baseline; 1 week + 24 weeks after treatment start

eGFR

Time Frame: Baseline; 1 week + 24 weeks after treatment start

Secondary Outcomes

  • Adverse Events(From signature of informed consent until last follow-up visit (36 months after treatment start))
  • Filtration fraction %(Baseline; 1 week + 24 weeks after treatment start)
  • Effective Renal Plasma Flow(Baseline; 1 week and 48 weeks after treatment start)
  • 24h Ambulatory Blood Pressure(Baseline; 1 week and 24 weeks after treatment start)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Antoinette Pechere-Bertschi, MD

Dr

University Hospital, Geneva

Study Sites (2)

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