Clinical trial NCT06580405: A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Severe Preeclampsia
Official title: A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Patients With Preeclampsia With Severe Features
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pre-Eclampsia, Severe
Lead sponsor: Kaneka Medical America LLC
Sponsor class: INDUSTRY
First posted: 2024-08-30
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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 \&lt; 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 \&lt; 100,000/mm3) at time of enrollment.
11. Anemia defined as hemoglobin \&lt; 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.

Primary outcomes:
measure: Antepartum maternal and fetal device-related serious adverse events
timeFrame: Until date of delivery
measure: Postpartum maternal and neonatal device-related serious adverse events
timeFrame: Following delivery until end of follow-up (2 years)
measure: Maternal, fetal, and neonatal mortality
timeFrame: Until end of follow-up (2 years)
measure: Obstetric complication
timeFrame: Until discharge or 6 weeks after delivery, whichever occurs first
measure: Fetal complications
timeFrame: Until date of delivery
measure: Neonatal morbidities associated with premature delivery
timeFrame: Following delivery until discharge or 6 weeks after delivery, whichever occurs first
measure: Neonatal intensive care unit (NICU) admissions
timeFrame: From date of NICU admission until the date of NICU discharge, assessed up to 24 months
Secondary outcomes:
measure: Prolongation of pregnancy
timeFrame: Until date of delivery
measure: Maternal systolic blood pressure
timeFrame: Until discharge or 6 weeks after delivery, whichever occurs first
measure: Maternal diastolic blood pressure
timeFrame: Until discharge or 6 weeks after delivery, whichever occurs first
measure: Maternal proteinuria
timeFrame: Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months
measure: Gestational age of the neonate at delivery
timeFrame: At date of delivery
measure: Weight of neonate at delivery
timeFrame: At date of delivery
measure: Amniotic fluid volume
timeFrame: Until the date of delivery, an average of 3 months
measure: Fetal umbilical artery flow
timeFrame: Until the date of delivery, an average of 3 months
measure: Uterine artery flow
timeFrame: Until the date of delivery, an average of 3 months
measure: Maternal low-density lipoprotein cholesterol (LDL-C) levels
timeFrame: Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months
measure: Fetal growth restriction
timeFrame: Until date of delivery
measure: APGAR scores
timeFrame: At date of delivery
measure: Umbilical artery and vein blood gases
timeFrame: At date of delivery
measure: Bayley Scales
timeFrame: At 6, 12, and 24 months after delivery
measure: Body weight of infant
timeFrame: Following delivery until end of follow-up (2 years)
measure: Body length and head circumference of infant
timeFrame: Following delivery until end of follow-up (2 years)
Other outcomes:
measure: Soluble fms-like tyrosine kinase-1 (sFlt-1)/ placental growth factor (PlGF) ratio in maternal serum
timeFrame: Until discharge or 6 weeks after delivery, whichever occurs first
measure: Percentage reduction of sFlt-1 levels in maternal serum
timeFrame: Until the date of delivery, an average of 3 months
measure: Change in sFLT-1 levels
timeFrame: During each apheresis procedure
measure: Change in PlGF levels
timeFrame: During each apheresis procedure
Locations:
Study officials:
References: