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A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Severe Preeclampsia | Clinical Trials | Clareo Health

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

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

NCT06580405•Kaneka Medical America LLC

View on ClinicalTrials.gov

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

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

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 \< 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.
•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.
+17 more criteria

Key Dates

Start Date

May 31, 2025

Primary Completion Date

April 30, 2026

Completion Date

June 30, 2028

Last Updated

March 5, 2025

Enrollment

ESTIMATED participants

Conditions

Pre-Eclampsia, Severe

Interventions

KNP-1000 Apheresis System

DEVICE

Contacts

Takashi Shimai

CONTACT

5105988423 Takashi.Shimai@kaneka.com

Takuji Nishide

CONTACT

5102030212 Takuji.Nishide@kaneka.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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