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

NCT01095939 | Completed Phase 3

• 1 other identifier: 09-136
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Renal Alteration

Keywords

Renal function consecutive to pre-eclampsia

Outcome Measures

Primary Outcomes (2)

• microalbuminuria excretion rate (spot or 24h)

  Baseline; 1 week + 24 weeks after treatment start

• eGFR

  Baseline; 1 week + 24 weeks after treatment start

Secondary Outcomes (4)

• Filtration fraction %

  Baseline; 1 week + 24 weeks after treatment start

• 24h Ambulatory Blood Pressure

  Baseline; 1 week and 24 weeks after treatment start

• Effective Renal Plasma Flow

  Baseline; 1 week and 48 weeks after treatment start

• Adverse Events

  From signature of informed consent until last follow-up visit (36 months after treatment start)

Study Arms (2)

Control Arm

PLACEBO COMPARATOR

Drug: Placebo

Benazepril

EXPERIMENTAL

Drug: Benazepril hydrochloride

Interventions

Placebo DRUG

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

Control Arm

Benazepril hydrochloride DRUG

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

Also known as: Cibacen, Lotensin, ATC: C09AA07

Benazepril

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (2)

Geneva University Hospitals

Geneva, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

Related Publications (1)

• Ditisheim A, Wuerzner G, Ponte B, Vial Y, Irion O, Burnier M, Boulvain M, Pechere-Bertschi A. Prevalence of Hypertensive Phenotypes After Preeclampsia: A Prospective Cohort Study. Hypertension. 2018 Jan;71(1):103-109. doi: 10.1161/HYPERTENSIONAHA.117.09799. Epub 2017 Nov 13.

  PMID: 29133363 DERIVED

MeSH Terms

Interventions

benazepril

Study Officials

• Antoinette Pechère

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: March 30, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2018
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

CH (2)