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

NCT ID: NCT04527328

Last Updated: 2022-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-28

Study Completion Date

2021-06-04

Brief Summary

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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.

Detailed Description

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In this study, approximately 26 men and women on dialysis due to end stage renal disease and who have cognitive impairment will be randomly assigned to receive AKST1210 or control during each hemodialysis session for 3 months. The primary objective is to assess the safety and tolerability of AKST1210, and secondary objectives include changes in cognitive assessments as well as the feasibility of using AKST1210 in this setting.

Conditions

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Cognitive Impairment End Stage Renal Disease

Keywords

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Renal disease Renal failure, chronic End stage kidney disease Chronic kidney failure Kidney disease Cognitive decline Mental deterioration Cognition disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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AKST1210

The AKST1210 column will be connected to the dialysis circuit during each dialysis session.

Group Type EXPERIMENTAL

AKST1210

Intervention Type DEVICE

AKST1210

Hemodialysis

Intervention Type PROCEDURE

Hemodialysis

Sham Control (No Intervention)

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

Group Type SHAM_COMPARATOR

Sham Control (No Intervention)

Intervention Type OTHER

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

Hemodialysis

Intervention Type PROCEDURE

Hemodialysis

Interventions

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AKST1210

AKST1210

Intervention Type DEVICE

Sham Control (No Intervention)

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

Intervention Type OTHER

Hemodialysis

Hemodialysis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* On chronic hemodialysis due to end-stage renal disease for ≥ 12 months.
* Score on the Montreal Cognitive Assessment (MoCA) ≥ 16 and ≤ 23.
* Body mass index (BMI) ≥ 20 and ≤ 36.
* The subject must be able to follow the study protocol, receive the treatment in the established timeframe, and continue during the follow-up interval.
* The subject must have sufficient visual and auditory acuity to reliably complete all study assessments.
* Provided a signed and dated informed consent form.

Exclusion Criteria

* Subjects for whom adequate anticoagulation cannot be achieved. Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is allowed.
* History of hypersensitivity to heparin.
* Pregnant or breast-feeding women or women who are planning to become pregnant.
* Clinically significant abnormalities on Screening ECG including QT interval corrected for heart rate (QTc) (using Fridericia's correction formula) of ≥ 500 ms in men and ≥ 520 ms in women.
* Clinically significant and unexpected abnormalities in this patient population in complete blood count, complete metabolic panel, coagulation, and thyroid stimulating hormone (TSH).
* Subjects with a hemoglobin level \< 9.0 g/dL.
* Concurrent or recent participation in another investigational clinical trial. Prior clinical trial subjects must have discontinued investigational agents at least 30 days prior to Screening.
* Subjects planning to receive renal transplantation during the study.
* Any other condition and/or situation that the investigator believes may interfere with the safety of the subject, study conduct, or interpretation of study data.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alkahest, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alkahest Medical Monitor

Role: STUDY_DIRECTOR

Alkahest, Inc.

Locations

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Renal Consultants Medical Group

Granada Hills, California, United States

Site Status

Valley Renal Medical Group

Northridge, California, United States

Site Status

Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

US Renal Care Kidney Research

San Antonio, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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AKST1210-201

Identifier Type: -

Identifier Source: org_study_id