Can a blood filter help mothers with severe preeclampsia carry longer?

NCT ID NCT06580405

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether a device called the KNP-1000 apheresis system is safe for pregnant women with severe preeclampsia and their babies. The device filters the mother's blood to remove a protein linked to the condition. Researchers will enroll about 13 women between 23 and 32 weeks of pregnancy and monitor for complications in both mother and baby. The main goal is safety, with a secondary look at whether treatment can prolong the pregnancy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KNP-1000 apheresis system, a device that filters the mother's blood to remove a protein called sFlt-1
What this could lead to
If safe and effective, this approach could help women with severe preeclampsia carry their pregnancies longer, reducing risks from premature birth.
What could go wrong
This is a very small feasibility study focused on safety, not proof of benefit. The device may not meaningfully improve outcomes, and there are inherent risks to both mother and fetus from the procedure and the condition itself.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 13 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. Maternal Exclusion Criteria: 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. 10. Thrombocytopenia (platelet count \< 100,000/mm3) at time of enrollment. 11. Anemia defined as hemoglobin \< 8 g/dL at time of enrollment. 12. 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. 13. Diagnosis of placenta previa during the current gestation period. 14. Preterm labor at or before time of screening. 15. Documented medical history of active hepatitis B virus, hepatitis C virus (HCV), syphilis, tuberculosis infection, or human immunodeficiency virus (HIV) positive status. 16. Any condition that the Investigator deems a risk to the study participant or fetus in completing the investigation. 17. Hypersensitivity to dextran sulfate cellulose or heparin. 18. Multiple gestation. 19. Documented history of familial hypercholesterolemia. 20. Suspicion or diagnosis of placental abruption during the current gestation. 21. 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. 22. Patients who have participated in another clinical trial within 6 months prior to enrollment. Fetal Exclusion Criteria: 1. Documented record of chromosomal anomalies. 2. Identifiable structural fetal abnormalities present at time of screening or a record of such abnormalities prior to enrollment. 3. Oligohydramnios, defined as Amniotic fluid index (AFI) less than 5 cm when measured using the four-quadrant method at time of enrollment. 4. Fetal growth restriction (FGR) defined as estimated fetal weight (EFW) below the 5th percentile for gestational age.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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