An interventional study of KNP-1000 Apheresis System in Pre-Eclampsia, Severe, sponsored by Kaneka Medical America LLC. Not yet recruiting. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Kaneka Medical America LLC (part of Kaneka Corporation) · Not applicable, Interventional, and Treatment
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).
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 13 is below the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Kaneka Medical America LLC is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A participant is deemed suitable for inclusion in the investigation if she meets the following criteria:
Exclusion Criteria:
A participant will be excluded from the investigation if any of the following maternal or fetal criteria are met.
Maternal Exclusion Criteria:
Fetal Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
sFlt-1 is removed from the participants' plasma through treatment.
Antepartum maternal and fetal device-related serious adverse events
Rate of antepartum maternal and fetal device-related serious adverse events
Time frame: Until date of delivery
Postpartum maternal and neonatal device-related serious adverse events
Rate of postpartum maternal and neonatal device-related serious adverse events
Time frame: Following delivery until end of follow-up (2 years)
Maternal, fetal, and neonatal mortality
Rate of maternal, fetal, and neonatal mortality
Time frame: Until end of follow-up (2 years)
Obstetric complication
Incidence rate of obstetric complication
Time frame: Until discharge or 6 weeks after delivery, whichever occurs first
Fetal complications
Incidence rate of fetal complications
Time frame: Until date of delivery
Neonatal morbidities associated with premature delivery
Incidence rate of neonatal morbidities associated with premature delivery
Time frame: 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
Time frame: From date of NICU admission until the date of NICU discharge, assessed up to 24 months
Prolongation of pregnancy
Number of days from enrollment to delivery
Time frame: Until date of delivery
Maternal systolic blood pressure
Change in maternal systolic blood pressure over the duration of the investigation
Time frame: Until discharge or 6 weeks after delivery, whichever occurs first
Maternal diastolic blood pressure
Change in maternal diastolic blood pressure over the duration of the investigation
Time frame: Until discharge or 6 weeks after delivery, whichever occurs first
Maternal proteinuria
Change in maternal proteinuria before and after each procedure
Time frame: Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months
Gestational age of the neonate at delivery
Gestational age of the neonate at delivery
Time frame: At date of delivery
Weight of neonate at delivery
Weight of neonate at delivery
Time frame: At date of delivery
Amniotic fluid volume
Change in amniotic fluid volume before and after each procedure
Time frame: Until the date of delivery, an average of 3 months
Fetal umbilical artery flow
Change in fetal umbilical artery flow before and after each procedure
Time frame: Until the date of delivery, an average of 3 months
Uterine artery flow
Change in uterine artery flow before and after each procedure
Time frame: Until the date of delivery, an average of 3 months
Maternal low-density lipoprotein cholesterol (LDL-C) levels
Change in LDL-C levels in maternal serum before and after each procedure
Time frame: Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months
Fetal growth restriction
Incidence rate of fetal growth restriction
Time frame: Until date of delivery
APGAR scores
Neonatal APGAR scores
Time frame: At date of delivery
Umbilical artery and vein blood gases
Umbilical artery and vein blood gases
Time frame: At date of delivery
Bayley Scales
Bayley Scales of Infant and Toddler Development, Fourth Edition assessment at 6, 12, and 24 months after delivery. Standard score (Composite score) range from 40 to 160, with higher scores indicating higher performance.
Time frame: At 6, 12, and 24 months after delivery
Body weight of infant
Body weight (grams) of infant at birth and during extended follow-up
Time frame: Following delivery until end of follow-up (2 years)
Body length and head circumference of infant
Body length and head circumference (centimeters) of infant at birth and during extended follow-up
Time frame: Following delivery until end of follow-up (2 years)
Soluble fms-like tyrosine kinase-1 (sFlt-1)/ placental growth factor (PlGF) ratio in maternal serum
sFlt-1/PlGF ratio in maternal serum
Time frame: Until discharge or 6 weeks after delivery, whichever occurs first
Percentage reduction of sFlt-1 levels in maternal serum
Percentage reduction of sFlt-1 levels in maternal serum after each apheresis treatment
Time frame: Until the date of delivery, an average of 3 months
Change in sFLT-1 levels
Change in sFLT-1 levels between the inlet and outlet of the apheresis system
Time frame: During each apheresis procedure
Change in PlGF levels
Change in PlGF levels between the inlet and outlet of the apheresis system
Time frame: During each apheresis procedure
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Aug 2027, 10 months later.
Of 176 interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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