A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Severe Preeclampsia
NCT Number: NCT06580405
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pre-Eclampsia, Severe
Sponsor: Kaneka Medical America LLC
Sex: FEMALE
Age: ADULT
Enrollment: 13
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2027-12-31

Summary:
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).

Primary Outcome Measures: Antepartum maternal and fetal device-related serious adverse events, Rate of antepartum maternal and fetal device-related serious adverse events, Until date of delivery|Postpartum maternal and neonatal device-related serious adverse events, Rate of postpartum maternal and neonatal device-related serious adverse events, Following delivery until end of follow-up (2 years)|Maternal, fetal, and neonatal mortality, Rate of maternal, fetal, and neonatal mortality, Until end of follow-up (2 years)|Obstetric complication, Incidence rate of obstetric complication, Until discharge or 6 weeks after delivery, whichever occurs first|Fetal complications, Incidence rate of fetal complications, Until date of delivery|Neonatal morbidities associated with premature delivery, Incidence rate of neonatal morbidities associated with premature delivery, Following delivery until discharge or 6 weeks after delivery, whichever occurs first|Neonatal intensive care unit (NICU) admissions, Rate of NICU admissions and length of stay, From date of NICU admission until the date of NICU discharge, assessed up to 24 months
Secondary Outcome Measures: Prolongation of pregnancy, Number of days from enrollment to delivery, Until date of delivery|Maternal systolic blood pressure, Change in maternal systolic blood pressure over the duration of the investigation, Until discharge or 6 weeks after delivery, whichever occurs first|Maternal diastolic blood pressure, Change in maternal diastolic blood pressure over the duration of the investigation, Until discharge or 6 weeks after delivery, whichever occurs first|Maternal proteinuria, Change in maternal proteinuria before and after each procedure, Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months|Gestational age of the neonate at delivery, Gestational age of the neonate at delivery, At date of delivery|Weight of neonate at delivery, Weight of neonate at delivery, At date of delivery|Amniotic fluid volume, Change in amniotic fluid volume before and after each procedure, Until the date of delivery, an average of 3 months|Fetal umbilical artery flow, Change in fetal umbilical artery flow before and after each procedure, Until the date of delivery, an average of 3 months|Uterine artery flow, Change in uterine artery flow before and after each procedure, Until the date of delivery, an average of 3 months|Maternal low-density lipoprotein cholesterol (LDL-C) levels, Change in LDL-C levels in maternal serum before and after each procedure, Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months|Fetal growth restriction, Incidence rate of fetal growth restriction, Until date of delivery|APGAR scores, Neonatal APGAR scores, At date of delivery|Umbilical artery and vein blood gases, Umbilical artery and vein blood gases, At date of delivery|Bayley Scales, Bayley Scales of Infant and Toddler Development, Fourth Edition assessment at 6, 12, and 24 months after delivery. Standard score (Composite score) range from 40 to 160, with higher scores indicating higher performance., At 6, 12, and 24 months after delivery|Body weight of infant, Body weight (grams) of infant at birth and during extended follow-up, Following delivery until end of follow-up (2 years)|Body length and head circumference of infant, Body length and head circumference (centimeters) of infant at birth and during extended follow-up, Following delivery until end of follow-up (2 years)
Other Outcome Measures: Soluble fms-like tyrosine kinase-1 (sFlt-1)/ placental growth factor (PlGF) ratio in maternal serum, sFlt-1/PlGF ratio in maternal serum, Until discharge or 6 weeks after delivery, whichever occurs first|Percentage reduction of sFlt-1 levels in maternal serum, Percentage reduction of sFlt-1 levels in maternal serum after each apheresis treatment, Until the date of delivery, an average of 3 months|Change in sFLT-1 levels, Change in sFLT-1 levels between the inlet and outlet of the apheresis system, During each apheresis procedure|Change in PlGF levels, Change in PlGF levels between the inlet and outlet of the apheresis system, During each apheresis procedure