Pre-Eclampsia, SevereNCT06580405
A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Severe Preeclampsia
A study testing KNP-1000 Apheresis System in people with Pre-Eclampsia, Severe, run by Kaneka Medical America LLC.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pre-Eclampsia, Severe
- What is being tested?
- KNP-1000 Apheresis System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- A participant is deemed suitable for inclusion in the investigation if she meets the following criteria:
- 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.
Who cannot join
- A participant will be excluded from the investigation if any of the following maternal or fetal criteria are met.
- Maternal Exclusion Criteria:
- 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.
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- Actively receiving therapeutic anticoagulation therapy or within the therapeutic window after ceasing anticoagulation therapy at the time of enrollment.
- Any condition which, in the opinion of the Investigator, would necessitate immediate delivery within 24 hours.
- 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).
- Confirmed or suspected diagnosis of pulmonary edema at time of enrollment.
- Diagnosis of HELLP syndrome.
- Thrombocytopenia (platelet count \< 100,000/mm3) at time of enrollment.
- Anemia defined as hemoglobin \< 8 g/dL at time of enrollment.
- 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.
- Diagnosis of placenta previa during the current gestation period.
- Preterm labor at or before time of screening.
- Documented medical history of active hepatitis B virus, hepatitis C virus (HCV), syphilis, tuberculosis infection, or human immunodeficiency virus (HIV) positive status.
- Any condition that the Investigator deems a risk to the study participant or fetus in completing the investigation.
- Hypersensitivity to dextran sulfate cellulose or heparin.
- Multiple gestation.
- Documented history of familial hypercholesterolemia.
- Suspicion or diagnosis of placental abruption during the current gestation.
- 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.
- Patients who have participated in another clinical trial within 6 months prior to enrollment.
- Fetal Exclusion Criteria:
- Documented record of chromosomal anomalies.
- Identifiable structural fetal abnormalities present at time of screening or a record of such abnormalities prior to enrollment.
- Oligohydramnios, defined as Amniotic fluid index (AFI) less than 5 cm when measured using the four-quadrant method at time of enrollment.
- Fetal growth restriction (FGR) defined as estimated fetal weight (EFW) below the 5th percentile for gestational age.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Patients With Preeclampsia With Severe Features
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).
- Conditions
- Pre-Eclampsia, Severe
- Being tested
- KNP-1000 Apheresis System
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KNP-1000 Apheresis SystemDevice
sFlt-1 is removed from the participants' plasma through treatment.
| Study group | Role | What they receive |
|---|---|---|
| KNP-1000 Apheresis System | Experimental | 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. Receives: Device: KNP-1000 Apheresis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antepartum maternal and fetal device-related serious adverse events
Rate of antepartum maternal and fetal device-related serious adverse events
Measured: Until date of delivery
Postpartum maternal and neonatal device-related serious adverse events
Rate of postpartum maternal and neonatal device-related serious adverse events
Measured: Following delivery until end of follow-up (2 years)
Maternal, fetal, and neonatal mortality
Rate of maternal, fetal, and neonatal mortality
Measured: Until end of follow-up (2 years)
Obstetric complication
Incidence rate of obstetric complication
Measured: Until discharge or 6 weeks after delivery, whichever occurs first
Fetal complications
Incidence rate of fetal complications
Measured: Until date of delivery
Neonatal morbidities associated with premature delivery
Incidence rate of neonatal morbidities associated with premature delivery
Measured: 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
Measured: From date of NICU admission until the date of NICU discharge, assessed up to 24 months
Secondary outcomes (16)
Prolongation of pregnancy
Number of days from enrollment to delivery
Measured: Until date of delivery
Maternal systolic blood pressure
Change in maternal systolic blood pressure over the duration of the investigation
Measured: 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
Measured: Until discharge or 6 weeks after delivery, whichever occurs first
Maternal proteinuria
Change in maternal proteinuria before and after each procedure
Measured: 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
Measured: At date of delivery
Weight of neonate at delivery
Weight of neonate at delivery
Measured: At date of delivery
Amniotic fluid volume
Change in amniotic fluid volume before and after each procedure
Measured: 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
Measured: Until the date of delivery, an average of 3 months
Uterine artery flow
Change in uterine artery flow before and after each procedure
Measured: 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
Measured: Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months
Fetal growth restriction
Incidence rate of fetal growth restriction
Measured: Until date of delivery
APGAR scores
Neonatal APGAR scores
Measured: At date of delivery
Umbilical artery and vein blood gases
Umbilical artery and vein blood gases
Measured: 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.
Measured: At 6, 12, and 24 months after delivery
Body weight of infant
Body weight (grams) of infant at birth and during extended follow-up
Measured: 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
Measured: Following delivery until end of follow-up (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Oct 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Eclampsia, SevereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaneka Medical America LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580405
- Sponsor's protocol ID
- KNP-1000-US01
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Patients With Preeclampsia With Severe Features
- ClinicalTrials.gov ID
- NCT06580405
- Acronym / sponsor ID
- KNP-1000-US01
- Conditions
- Pre-Eclampsia, Severe
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Kaneka Medical America LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KNP-1000 Apheresis System | Experimental | Device: KNP-1000 Apheresis SystemParticipants are to be treated with the system up to 2 times per week, continuing through delivery or 34 weeks of pregnancy, whichever comes first. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A participant is deemed suitable for inclusion in the investigation if she meets the following criteria:
- 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.
Key exclusion criteria (29 listed)
- A participant will be excluded from the investigation if any of the following maternal or fetal criteria are met.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KNP-1000 Apheresis SystemsFlt-1 is removed from the participants' plasma through treatment. | Device | KNP-1000 Apheresis System |
Primary outcome
Antepartum maternal and fetal device-related serious adverse events
Time frame: Until date of delivery
Rate of antepartum maternal and fetal device-related serious adverse events
Postpartum maternal and neonatal device-related serious adverse events
Time frame: Following delivery until end of follow-up (2 years)
Rate of postpartum maternal and neonatal device-related serious adverse events
Maternal, fetal, and neonatal mortality
Time frame: Until end of follow-up (2 years)
Rate of maternal, fetal, and neonatal mortality
Obstetric complication
Time frame: Until discharge or 6 weeks after delivery, whichever occurs first
Incidence rate of obstetric complication
Fetal complications
Time frame: Until date of delivery
Incidence rate of fetal complications
Neonatal morbidities associated with premature delivery
Time frame: 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
Time frame: From date of NICU admission until the date of NICU discharge, assessed up to 24 months
Rate of NICU admissions and length of stay
16 secondary outcomes
Prolongation of pregnancy
Time frame: Until date of delivery
Maternal systolic blood pressure
Time frame: Until discharge or 6 weeks after delivery, whichever occurs first
Maternal diastolic blood pressure
Time frame: Until discharge or 6 weeks after delivery, whichever occurs first
Maternal proteinuria
Time frame: Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months
Gestational age of the neonate at delivery
Time frame: At date of delivery
Weight of neonate at delivery
Time frame: At date of delivery
Amniotic fluid volume
Time frame: Until the date of delivery, an average of 3 months
Fetal umbilical artery flow
Time frame: Until the date of delivery, an average of 3 months
Uterine artery flow
Time frame: Until the date of delivery, an average of 3 months
Maternal low-density lipoprotein cholesterol (LDL-C) levels
Time frame: Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months
Fetal growth restriction
Time frame: Until date of delivery
APGAR scores
Time frame: At date of delivery
Umbilical artery and vein blood gases
Time frame: At date of delivery
Bayley Scales
Time frame: At 6, 12, and 24 months after delivery
Body weight of infant
Time frame: Following delivery until end of follow-up (2 years)
Body length and head circumference of infant
Time frame: Following delivery until end of follow-up (2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing KNP-1000 Apheresis System in people with Pre-Eclampsia, Severe, run by Kaneka Medical America LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takashi Shimai (5105988423, Takashi.Shimai@kaneka.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antepartum maternal and fetal device-related serious adverse events (time frame: Until date of delivery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.