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 range18 Years – 45 Years

SexFEMALE

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.
✕. 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.

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 range18 Years – 45 Years

SexFEMALE

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.
✕. 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.

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