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A Study to Assess the Tolerability and Efficacy of AKST1210 in Patients on Hemodialysis With Cognitive Impairment

NCT04527328 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-12-12

Study results available
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Summary

This study will evaluate the tolerability, feasibility, and efficacy of the AKST1210 column in subjects with end-stage renal disease with cognitive impairment (ESRD-CI) undergoing hemodialysis 3 times per week.

Conditions

Interventions

DEVICE

AKST1210

AKST1210

OTHER

Sham Control (No Intervention)

A covered surrogate object of similar size and shape as the investigational device

PROCEDURE

Hemodialysis

Hemodialysis

Sponsors & Collaborators

  • Alkahest, Inc.

    lead INDUSTRY

Principal Investigators

  • Alkahest Medical Monitor · Alkahest, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-28
Primary Completion
2021-06-04
Completion
2021-06-04
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04527328 on ClinicalTrials.gov