The study will primarily evaluate safety of the KNP-1000 apheresis system for pregnant women and their fetuses diagnosed with preeclampsia with severe features between 23- and 32-weeks' gestation (very preterm).
Pregnant woman ≥ 23 0/7 and < 32 0/7 weeks gestation, aged 18 to 45 years, hospitalized for preeclampsia at time of enrollment.
Severe hypertension ever defined by resting systolic BP ≥ 160 mm Hg and/or diastolic BP ≥ 110 mm Hg on two occasions measured at least 4 hours apart.
Proteinuria, defined as ≥ 300 mg protein in a 24-hour urine collection or ≥ 0.3 protein/creatinine ratio.
Provision of signed and dated informed consent form.
Documented history of chronic hypertension, defined as systolic BP ≥ 140mmHg and/or systolic BP ≥ 90 mmHg before pregnancy or prior to 20 weeks of gestation.
Documented history of proteinuria prior to pregnancy or prior to 20 weeks of gestation.
Taking any form of angiotensin cascade blocker or angiotensin-converting enzyme (ACE) inhibitor at time of enrollment.
Documented history of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease.
Single group
KNP-1000 Apheresis System
DevicesFlt-1 is removed from the participants' plasma through treatment.
Antepartum maternal and fetal device-related serious adverse events
Rate of antepartum maternal and fetal device-related serious adverse events
Postpartum maternal and neonatal device-related serious adverse events
Rate of postpartum maternal and neonatal device-related serious adverse events
Maternal, fetal, and neonatal mortality
Rate of maternal, fetal, and neonatal mortality
Obstetric complication
Incidence rate of obstetric complication
Prolongation of pregnancy
Number of days from enrollment to delivery
Maternal systolic blood pressure
Change in maternal systolic blood pressure over the duration of the investigation
Maternal diastolic blood pressure
Change in maternal diastolic blood pressure over the duration of the investigation
Maternal proteinuria
Change in maternal proteinuria before and after each procedure
Soluble fms-like tyrosine kinase-1 (sFlt-1)/ placental growth factor (PlGF) ratio in maternal serum
sFlt-1/PlGF ratio in maternal serum
Percentage reduction of sFlt-1 levels in maternal serum
Percentage reduction of sFlt-1 levels in maternal serum after each apheresis treatment
Change in sFLT-1 levels
Change in sFLT-1 levels between the inlet and outlet of the apheresis system
Change in PlGF levels
Change in PlGF levels between the inlet and outlet of the apheresis system
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
