At a glance

ClinicalIndex Comparison Record

N/ACompleted· 10 enrolled

Drug / intervention

AKST1210 S-15 at 250 mL/min +5 moredevice

Likely dose

AKST1210 S-15 at 250 mL/minfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04985383

NCT04985383N/ACompleted

Compare CT.gov

An Open Label Phase 1 Study to Compare the Safety and Tolerability of the AKST1210 Column at Different Blood-Flow Rates in Patients With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis (HD)

Alkahest, Inc.·interventional·Posted Aug 2, 2021·Updated Sep 29, 2023

In Brief

A clinical study evaluating AKST1210 S-15 at 250 mL/min, AKST1210 S-15 at 450 mL/min, and 4 other interventions for End-Stage Renal Disease. Completed, enrolled 10 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsEnd-Stage Renal Disease

CountriesUnited States

Collaborators--

Timeline

N/ACompletedFinished

20222023202420252026

Enrollment StartMar 2021

First PostedAug 2021

Primary CompletionSep 2021

TodayJul 2026

First PostedAug 2, 2021

Enrollment StartMar 11, 2021

Primary CompletionSep 1, 2021

TodayJul 2, 2026

Enrollment to primary: 6 monthsPosted 4.9 years ago

Interventions

AKST1210 S-15 at 250 mL/mindevice

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

AKST1210 S-15 at 450 mL/mindevice

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

AKST1210 S-25 at 250 mL/mindevice

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

AKST1210 S-25 at 450 mL/mindevice

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

AKST1210 S-35 at 250 mL/mindevice

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

AKST1210 S-35 at 450 mL/mindevice

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