Renal Alteration | Post-preeclampsia Renal Project: Study of Nephroprotection in Women Having Suffered Preeclampsia
Renal Alteration research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:PlaceboTablets; 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
Drug:Benazepril hydrochlorideTablets (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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: April 2010
Completed Date: March 2018
Phase: Phase 3
Primary Outcome: microalbuminuria excretion rate (spot or 24h)
Secondary Outcome: Filtration fraction %
Study sponsors, principal investigator, and references
Principal Investigator: Antoinette Pechère
Lead Sponsor: University Hospital, Geneva