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Study to Compare Safety and Tolerability of AKST1210 Column at 2 Blood Flow Rates in Subjects With ESRD on Hemodialysis

NCT04985383 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-09-29

Study results available
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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.

Conditions

  • End-Stage Renal Disease

Interventions

DEVICE

AKST1210 S-15 at 250 mL/min

Procedure: Hemodialysis, AKST1210 column size 150mL and blood-flow rate at 250mL/min

DEVICE

AKST1210 S-15 at 450 mL/min

Procedure: Hemodialysis, AKST1210 column size 150mL and blood-flow rate at 450mL/min

DEVICE

AKST1210 S-25 at 250 mL/min

Procedure: Hemodialysis, AKST1210 column size 250mL and blood-flow rate at 250mL/min

DEVICE

AKST1210 S-25 at 450 mL/min

Procedure: Hemodialysis, AKST1210 column size 250mL and blood-flow rate at 450mL/min

DEVICE

AKST1210 S-35 at 250 mL/min

Procedure: Hemodialysis, AKST1210 column size 350mL and blood-flow rate at 250mL/min

DEVICE

AKST1210 S-35 at 450 mL/min

Procedure: Hemodialysis, AKST1210 column size 350mL and blood-flow rate at 450mL/min

Sponsors & Collaborators

  • Alkahest, Inc.

    lead INDUSTRY

Principal Investigators

  • Alkahest Medical Monitor · Alkahest, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-11
Primary Completion
2021-09-01
Completion
2021-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04985383 on ClinicalTrials.gov