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

NCT06580405 | Not Yet Recruiting FDA Device

• 1 other identifier: KNP-1000-US01
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Pre-Eclampsia, Severe

Outcome Measures

Primary Outcomes (7)

• Antepartum maternal and fetal device-related serious adverse events

  Rate of antepartum maternal and fetal device-related serious adverse events

  Until date of delivery

• Postpartum maternal and neonatal device-related serious adverse events

  Rate of postpartum maternal and neonatal device-related serious adverse events

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

• Maternal, fetal, and neonatal mortality

  Rate of maternal, fetal, and neonatal mortality

  Until end of follow-up (2 years)

• Obstetric complication

  Incidence rate of obstetric complication

  Until discharge or 6 weeks after delivery, whichever occurs first

• Fetal complications

  Incidence rate of fetal complications

  Until date of delivery

• Neonatal morbidities associated with premature delivery

  Incidence rate of neonatal morbidities associated with premature delivery

  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

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

Secondary Outcomes (16)

• Prolongation of pregnancy

  Until date of delivery

• Maternal systolic blood pressure

  Until discharge or 6 weeks after delivery, whichever occurs first

• Maternal diastolic blood pressure

  Until discharge or 6 weeks after delivery, whichever occurs first

• Maternal proteinuria

  Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months

• Gestational age of the neonate at delivery

  At date of delivery

Other Outcomes (4)

• Soluble fms-like tyrosine kinase-1 (sFlt-1)/ placental growth factor (PlGF) ratio in maternal serum

  Until discharge or 6 weeks after delivery, whichever occurs first

• Percentage reduction of sFlt-1 levels in maternal serum

  Until the date of delivery, an average of 3 months

• Change in sFLT-1 levels

  During each apheresis procedure

Study Arms (1)

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.

Device: KNP-1000 Apheresis System

Interventions

KNP-1000 Apheresis System DEVICE

sFlt-1 is removed from the participants' plasma through treatment.

KNP-1000 Apheresis System

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Kaneka Medical America LLC: lead

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Takashi Shimai

CONTACT

5105988423; Takashi.Shimai@kaneka.com

Takuji Nishide

CONTACT

5102030212; Takuji.Nishide@kaneka.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 30, 2024
• Study Start: May 31, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 5, 2025

Record last verified: 2025-03