A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Severe Preeclampsia

Not Applicable

Not yet recruiting

• Conditions: Pre-Eclampsia, Severe

• Registration Number: NCT06580405
• Lead Sponsor: Kaneka Medical America LLC

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-28
• Study First Posted: 2024-08-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Study Start: 2025-05-31
• Primary Completion: 2026-04-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 13

Inclusion Criteria

A participant is deemed suitable for inclusion in the investigation if she meets the following criteria:

1. Pregnant woman ≥ 23 0/7 and < 32 0/7 weeks gestation, aged 18 to 45 years, hospitalized for preeclampsia at time of enrollment.
2. 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.
3. Proteinuria, defined as ≥ 300 mg protein in a 24-hour urine collection or ≥ 0.3 protein/creatinine ratio.
4. Provision of signed and dated informed consent form.

Exclusion Criteria

A participant will be excluded from the investigation if any of the following maternal or fetal criteria are met.

Maternal Exclusion Criteria:

1. 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.
2. Documented history of proteinuria prior to pregnancy or prior to 20 weeks of gestation.
3. Taking any form of angiotensin cascade blocker or angiotensin-converting enzyme (ACE) inhibitor at time of enrollment.
4. Documented history of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease.
5. Actively receiving therapeutic anticoagulation therapy or within the therapeutic window after ceasing anticoagulation therapy at the time of enrollment.
6. Any condition which, in the opinion of the Investigator, would necessitate immediate delivery within 24 hours.
7. Signs or history of cerebral nervous system dysfunction, including seizures, cerebral edema (previously confirmed by computed tomography scan or magnetic resonance imaging per medical records).
8. Confirmed or suspected diagnosis of pulmonary edema at time of enrollment.
9. Diagnosis of HELLP syndrome.
10. Thrombocytopenia (platelet count < 100,000/mm3) at time of enrollment.
11. Anemia defined as hemoglobin < 8 g/dL at time of enrollment.
12. Absent or reverse flow on umbilical Doppler ultrasound exam at the time of screening, or documented history of negative or reverse flow during the current gestation period.
13. Diagnosis of placenta previa during the current gestation period.
14. Preterm labor at or before time of screening.
15. Documented medical history of active hepatitis B virus, hepatitis C virus (HCV), syphilis, tuberculosis infection, or human immunodeficiency virus (HIV) positive status.
16. Any condition that the Investigator deems a risk to the study participant or fetus in completing the investigation.
17. Hypersensitivity to dextran sulfate cellulose or heparin.
18. Multiple gestation.
19. Documented history of familial hypercholesterolemia.
20. Suspicion or diagnosis of placental abruption during the current gestation.
21. Patients who have received the drug treatment not recommended by the American College of Obstetricians and Gynecologists (ACOG) practice bulletin Gestational Hypertension and Preeclampsia (the clinical management guidelines) within 6 months prior to enrollment.
22. Patients who have participated in another clinical trial within 6 months prior to enrollment.

Fetal Exclusion Criteria:

1. Documented record of chromosomal anomalies.
2. Identifiable structural fetal abnormalities present at time of screening or a record of such abnormalities prior to enrollment.
3. Oligohydramnios, defined as Amniotic fluid index (AFI) less than 5 cm when measured using the four-quadrant method at time of enrollment.
4. Fetal growth restriction (FGR) defined as estimated fetal weight (EFW) below the 5th percentile for gestational age.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Antepartum maternal and fetal device-related serious adverse events	Until date of delivery	Rate of antepartum maternal and fetal device-related serious adverse events
Maternal, fetal, and neonatal mortality	Until end of follow-up (2 years)	Rate of maternal, fetal, and neonatal mortality
Fetal complications	Until date of delivery	Incidence rate of fetal complications
Postpartum maternal and neonatal device-related serious adverse events	Following delivery until end of follow-up (2 years)	Rate of postpartum maternal and neonatal device-related serious adverse events
Neonatal morbidities associated with premature delivery	Following delivery until discharge or 6 weeks after delivery, whichever occurs first	Incidence rate of neonatal morbidities associated with premature delivery
Neonatal intensive care unit (NICU) admissions	From date of NICU admission until the date of NICU discharge, assessed up to 24 months	Rate of NICU admissions and length of stay
Obstetric complication	Until discharge or 6 weeks after delivery, whichever occurs first	Incidence rate of obstetric complication

Secondary Outcome Measures

Name	Time	Method
Prolongation of pregnancy	Until date of delivery	Number of days from enrollment to delivery
Fetal umbilical artery flow	Until the date of delivery, an average of 3 months	Change in fetal umbilical artery flow before and after each procedure
Fetal growth restriction	Until date of delivery	Incidence rate of fetal growth restriction
Umbilical artery and vein blood gases	At date of delivery	Umbilical artery and vein blood gases
Bayley Scales	At 6, 12, and 24 months after delivery	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.
Maternal systolic blood pressure	Until discharge or 6 weeks after delivery, whichever occurs first	Change in maternal systolic blood pressure over the duration of the investigation
Uterine artery flow	Until the date of delivery, an average of 3 months	Change in uterine artery flow before and after each procedure
Maternal diastolic blood pressure	Until discharge or 6 weeks after delivery, whichever occurs first	Change in maternal diastolic blood pressure over the duration of the investigation
Maternal proteinuria	Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months	Change in maternal proteinuria before and after each procedure
Gestational age of the neonate at delivery	At date of delivery	Gestational age of the neonate at delivery
Amniotic fluid volume	Until the date of delivery, an average of 3 months	Change in amniotic fluid volume before and after each procedure
Maternal low-density lipoprotein cholesterol (LDL-C) levels	Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months	Change in LDL-C levels in maternal serum before and after each procedure
APGAR scores	At date of delivery	Neonatal APGAR scores
Weight of neonate at delivery	At date of delivery	Weight of neonate at delivery
Body weight of infant	Following delivery until end of follow-up (2 years)	Body weight (grams) of infant at birth and during extended follow-up
Body length and head circumference of infant	Following delivery until end of follow-up (2 years)	Body length and head circumference (centimeters) of infant at birth and during extended follow-up