Status:
NOT_YET_RECRUITING
A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Severe Preeclampsia
Lead Sponsor:
Kaneka Medical America LLC
Conditions:
Pre-Eclampsia, Severe
Eligibility:
FEMALE
18-45 years
Phase:
NA
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 (ver...
Eligibility Criteria
Inclusion
- A participant is deemed suitable for inclusion in the investigation if she meets the following 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
- A participant will be excluded from the investigation if any of the following maternal or fetal criteria are met.
- Maternal
Key Trial Info
Start Date :
May 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT06580405
Start Date
May 31 2025
End Date
June 30 2028
Last Update
March 5 2025
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