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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later Apr 30, 2026 → Aug 31, 2027
See other at-risk trials from Kaneka Medical America LLC

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Apr 30, 2026 to Aug 31, 2027
    • Start date: May 31, 2025 to Oct 1, 2026
    • Study completion pushed from Jun 30, 2028 to Nov 30, 2029
    v3
  2. Primary completion date: Oct 31, 2025 to Apr 30, 2026
    • Start date: Dec 1, 2024 to May 31, 2025
    • Study completion date: Dec 31, 2027 to Jun 30, 2028
    • Eligibility criteria shortened, about 7 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06580405
Lead Sponsor Kaneka Medical America LLC
Conditions
(from sponsor)		 Pre-Eclampsia, Severe
Related terms Pre-Eclampsia
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov