Not Yet RecruitingNot Applicable

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

13 participantsStarted 2025-05-31

Plain-language 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).

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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.

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.
. Actively receiving therapeutic anticoagulation therapy or within the therapeutic window after ceasing anticoagulation therapy at the time of enrollment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Antepartum maternal and fetal device-related serious adverse events

Timeframe: Until date of delivery

Postpartum maternal and neonatal device-related serious adverse events

Timeframe: Following delivery until end of follow-up (2 years)

Maternal, fetal, and neonatal mortality

Timeframe: Until end of follow-up (2 years)

Obstetric complication

Timeframe: Until discharge or 6 weeks after delivery, whichever occurs first

Fetal complications

Timeframe: Until date of delivery

Neonatal morbidities associated with premature delivery

Timeframe: Following delivery until discharge or 6 weeks after delivery, whichever occurs first

Neonatal intensive care unit (NICU) admissions

Timeframe: From date of NICU admission until the date of NICU discharge, assessed up to 24 months

Trial details

NCT IDNCT06580405

SponsorKaneka Medical America LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-30

Contact for this trial

Takashi Shimai

5105988423 Takashi.Shimai@kaneka.com

View on ClinicalTrials.gov More Pre-Eclampsia, Severe trials

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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.

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.
. Actively receiving therapeutic anticoagulation therapy or within the therapeutic window after ceasing anticoagulation therapy at the time of enrollment.

What they're measuring

Antepartum maternal and fetal device-related serious adverse events

Timeframe: Until date of delivery

Postpartum maternal and neonatal device-related serious adverse events

Timeframe: Following delivery until end of follow-up (2 years)

Maternal, fetal, and neonatal mortality

Timeframe: Until end of follow-up (2 years)

Obstetric complication

Timeframe: Until discharge or 6 weeks after delivery, whichever occurs first

Fetal complications

Timeframe: Until date of delivery

Neonatal morbidities associated with premature delivery

Timeframe: Following delivery until discharge or 6 weeks after delivery, whichever occurs first

Neonatal intensive care unit (NICU) admissions

Timeframe: From date of NICU admission until the date of NICU discharge, assessed up to 24 months