Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-03-02 @ 9:13 PM
Study NCT ID:
NCT06580405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-05
First Post:
2024-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Severe Preeclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 13}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2024-08-28', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'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', 'description': 'sFlt-1/PlGF ratio in maternal serum'}, {'measure': 'Percentage reduction of sFlt-1 levels in maternal serum', 'timeFrame': 'Until the date of delivery, an average of 3 months', 'description': 'Percentage reduction of sFlt-1 levels in maternal serum after each apheresis treatment'}, {'measure': 'Change in sFLT-1 levels', 'timeFrame': 'During each apheresis procedure', 'description': 'Change in sFLT-1 levels between the inlet and outlet of the apheresis system'}, {'measure': 'Change in PlGF levels', 'timeFrame': 'During each apheresis procedure', 'description': 'Change in PlGF levels between the inlet and outlet of the apheresis system'}], 'primaryOutcomes': [{'measure': 'Antepartum maternal and fetal device-related serious adverse events', 'timeFrame': 'Until date of delivery', 'description': 'Rate of antepartum maternal and fetal device-related serious adverse events'}, {'measure': 'Postpartum maternal and neonatal device-related serious adverse events', 'timeFrame': 'Following delivery until end of follow-up (2 years)', 'description': 'Rate of postpartum maternal and neonatal device-related serious adverse events'}, {'measure': 'Maternal, fetal, and neonatal mortality', 'timeFrame': 'Until end of follow-up (2 years)', 'description': 'Rate of maternal, fetal, and neonatal mortality'}, {'measure': 'Obstetric complication', 'timeFrame': 'Until discharge or 6 weeks after delivery, whichever occurs first', 'description': 'Incidence rate of obstetric complication'}, {'measure': 'Fetal complications', 'timeFrame': 'Until date of delivery', 'description': 'Incidence rate of fetal complications'}, {'measure': 'Neonatal morbidities associated with premature delivery', 'timeFrame': 'Following delivery until discharge or 6 weeks after delivery, whichever occurs first', 'description': 'Incidence rate of neonatal morbidities associated with premature delivery'}, {'measure': 'Neonatal intensive care unit (NICU) admissions', 'timeFrame': 'From date of NICU admission until the date of NICU discharge, assessed up to 24 months', 'description': 'Rate of NICU admissions and length of stay'}], 'secondaryOutcomes': [{'measure': 'Prolongation of pregnancy', 'timeFrame': 'Until date of delivery', 'description': 'Number of days from enrollment to delivery'}, {'measure': 'Maternal systolic blood pressure', 'timeFrame': 'Until discharge or 6 weeks after delivery, whichever occurs first', 'description': 'Change in maternal systolic blood pressure over the duration of the investigation'}, {'measure': 'Maternal diastolic blood pressure', 'timeFrame': 'Until discharge or 6 weeks after delivery, whichever occurs first', 'description': 'Change in maternal diastolic blood pressure over the duration of the investigation'}, {'measure': 'Maternal proteinuria', 'timeFrame': 'Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months', 'description': 'Change in maternal proteinuria before and after each procedure'}, {'measure': 'Gestational age of the neonate at delivery', 'timeFrame': 'At date of delivery', 'description': 'Gestational age of the neonate at delivery'}, {'measure': 'Weight of neonate at delivery', 'timeFrame': 'At date of delivery', 'description': 'Weight of neonate at delivery'}, {'measure': 'Amniotic fluid volume', 'timeFrame': 'Until the date of delivery, an average of 3 months', 'description': 'Change in amniotic fluid volume before and after each procedure'}, {'measure': 'Fetal umbilical artery flow', 'timeFrame': 'Until the date of delivery, an average of 3 months', 'description': 'Change in fetal umbilical artery flow before and after each procedure'}, {'measure': 'Uterine artery flow', 'timeFrame': 'Until the date of delivery, an average of 3 months', 'description': 'Change in uterine artery flow before and after each procedure'}, {'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', 'description': 'Change in LDL-C levels in maternal serum before and after each procedure'}, {'measure': 'Fetal growth restriction', 'timeFrame': 'Until date of delivery', 'description': 'Incidence rate of fetal growth restriction'}, {'measure': 'APGAR scores', 'timeFrame': 'At date of delivery', 'description': 'Neonatal APGAR scores'}, {'measure': 'Umbilical artery and vein blood gases', 'timeFrame': 'At date of delivery', 'description': 'Umbilical artery and vein blood gases'}, {'measure': 'Bayley Scales', 'timeFrame': 'At 6, 12, and 24 months after delivery', 'description': '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.'}, {'measure': 'Body weight of infant', 'timeFrame': 'Following delivery until end of follow-up (2 years)', 'description': 'Body weight (grams) of infant at birth and during extended follow-up'}, {'measure': 'Body length and head circumference of infant', 'timeFrame': 'Following delivery until end of follow-up (2 years)', 'description': 'Body length and head circumference (centimeters) of infant at birth and during extended follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pre-Eclampsia, Severe']}, 'descriptionModule': {'briefSummary': "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)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA participant is deemed suitable for inclusion in the investigation if she meets the following criteria:\n\n1. Pregnant woman ≥ 23 0/7 and \\< 32 0/7 weeks gestation, aged 18 to 45 years, hospitalized for preeclampsia at time of enrollment.\n2. 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.\n3. Proteinuria, defined as ≥ 300 mg protein in a 24-hour urine collection or ≥ 0.3 protein/creatinine ratio.\n4. Provision of signed and dated informed consent form.\n\nExclusion Criteria:\n\nA participant will be excluded from the investigation if any of the following maternal or fetal criteria are met.\n\nMaternal Exclusion Criteria:\n\n1. 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.\n2. Documented history of proteinuria prior to pregnancy or prior to 20 weeks of gestation.\n3. Taking any form of angiotensin cascade blocker or angiotensin-converting enzyme (ACE) inhibitor at time of enrollment.\n4. Documented history of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease.\n5. Actively receiving therapeutic anticoagulation therapy or within the therapeutic window after ceasing anticoagulation therapy at the time of enrollment.\n6. Any condition which, in the opinion of the Investigator, would necessitate immediate delivery within 24 hours.\n7. 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).\n8. Confirmed or suspected diagnosis of pulmonary edema at time of enrollment.\n9. Diagnosis of HELLP syndrome.\n10. Thrombocytopenia (platelet count \\< 100,000/mm3) at time of enrollment.\n11. Anemia defined as hemoglobin \\< 8 g/dL at time of enrollment.\n12. 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.\n13. Diagnosis of placenta previa during the current gestation period.\n14. Preterm labor at or before time of screening.\n15. Documented medical history of active hepatitis B virus, hepatitis C virus (HCV), syphilis, tuberculosis infection, or human immunodeficiency virus (HIV) positive status.\n16. Any condition that the Investigator deems a risk to the study participant or fetus in completing the investigation.\n17. Hypersensitivity to dextran sulfate cellulose or heparin.\n18. Multiple gestation.\n19. Documented history of familial hypercholesterolemia.\n20. Suspicion or diagnosis of placental abruption during the current gestation.\n21. 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.\n22. Patients who have participated in another clinical trial within 6 months prior to enrollment.\n\nFetal Exclusion Criteria:\n\n1. Documented record of chromosomal anomalies.\n2. Identifiable structural fetal abnormalities present at time of screening or a record of such abnormalities prior to enrollment.\n3. Oligohydramnios, defined as Amniotic fluid index (AFI) less than 5 cm when measured using the four-quadrant method at time of enrollment.\n4. Fetal growth restriction (FGR) defined as estimated fetal weight (EFW) below the 5th percentile for gestational age.'}, 'identificationModule': {'nctId': 'NCT06580405', 'briefTitle': 'A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Severe Preeclampsia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kaneka Medical America LLC'}, 'officialTitle': 'A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Patients With Preeclampsia With Severe Features', 'orgStudyIdInfo': {'id': 'KNP-1000-US01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KNP-1000 Apheresis System', 'description': 'Participants are to be treated with the system up to 2 times per week, continuing through delivery or 34 weeks of pregnancy, whichever comes first.', 'interventionNames': ['Device: KNP-1000 Apheresis System']}], 'interventions': [{'name': 'KNP-1000 Apheresis System', 'type': 'DEVICE', 'description': "sFlt-1 is removed from the participants' plasma through treatment.", 'armGroupLabels': ['KNP-1000 Apheresis System']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Takashi Shimai', 'role': 'CONTACT', 'email': 'Takashi.Shimai@kaneka.com', 'phone': '5105988423'}, {'name': 'Takuji Nishide', 'role': 'CONTACT', 'email': 'Takuji.Nishide@kaneka.com', 'phone': '5102030212'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaneka Medical America LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}