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NCT04985383 · ClinicalTrials.gov registry record · NA
Study to Compare Safety and Tolerability of AKST1210 Column at 2 Blood Flow Rates in Subjects With ESRD on Hemodialysis
A NA study, sponsored by Alkahest.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT04985383: Completed NA study, sponsored by Alkahest.
NCT04985383 is a NA study that has completed, run by Alkahest. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04985383, a NA study, has completed, sponsored by Alkahest.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study is to evaluate the safety and tolerability of the AKST1210 column at blood-flow rates greater than 250 mL/min in subjects with end-stage renal disease (ESRD) undergoing hemodialysis (HD). The study will assess the safety, tolerability, and impact on HD parameters when the AKST1210 column is used at a blood-flow of up to 450 mL/min.
Primary Outcome
A TEAE is defined as an AE that occurs on or after the date of the first column use. Primary and secondary endpoints were assessed at the beginning and end of each week of treatment for a particular column size and blood-flow rate combination (S-15 250 mL/min, S-15 up to 450 mL/min, S-25 250 mL/min, S-25 up to 450 mL/min, S-35 250 mL/min, S-35 up to 450 mL/min). The effect of blood-flow rate was assessed for a given column size as well as intra-subject and across-subject variability.
Interventions
- DEVICE AKST1210 S-15 at 250 mL/min
- DEVICE AKST1210 S-15 at 450 mL/min
- DEVICE AKST1210 S-25 at 250 mL/min
- DEVICE AKST1210 S-25 at 450 mL/min
- DEVICE AKST1210 S-35 at 250 mL/min
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-03-11 |
| Est. Completion | 2021-09-01 |
| Phase | NA |
What the finished NCT04985383 record still lists
NCT04985383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which AKST1210 S-15 at 250 mL/min is the first listed.
NCT04985383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04985383 about?
NCT04985383 is a clinical study titled "Study to Compare Safety and Tolerability of AKST1210 Column at 2 Blood Flow Rates in Subjects With ESRD on Hemodialysis". This study is to evaluate the safety and tolerability of the AKST1210 column at blood-flow rates greater than 250 mL/min in subjects with end-stage renal disease (ESRD) undergoing hemodialysis (HD). The study will assess the safety, tolerability, and impact on HD parameters when the AKST1210 column ...
What is the current status of trial NCT04985383?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2021-03-11. Estimated completion is 2021-09-01.
What interventions are being tested in trial NCT04985383?
The interventions under investigation include: AKST1210 S-15 at 250 mL/min (DEVICE), AKST1210 S-15 at 450 mL/min (DEVICE), AKST1210 S-25 at 250 mL/min (DEVICE), AKST1210 S-25 at 450 mL/min (DEVICE), AKST1210 S-35 at 250 mL/min (DEVICE).
Who is sponsoring clinical trial NCT04985383?
This trial is sponsored by Alkahest, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04985383's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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