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

NCT04527328 | Completed Results DMC FDA Device

• 1 other identifier: AKST1210-201
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief 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

Cognitive Impairment; End Stage Renal Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events Assessed by Intensity

  Number of participants with Treatment-Emergent Adverse Events (TEAE) assessed by Intensity (mild, moderate, or severe) coded by the Medical Dictionary for Regulatory Activities (MedDRA)

  Baseline to Week 14

Secondary Outcomes (14)

• Tolerability as Measured by the Number of Subjects Who Complete Each Treatment Period

  Baseline to Week 12

• Number of Participants Who Discontinued Due to Intradialytic Hypotension (IDH)

  Baseline to Week 12

• Change From Baseline in Montreal Cognitive Assessment (MoCA)

  Screening to Week 14

• Change From Baseline in Computer-based Cognitive Assessment (CogState) Composite Score

  Baseline to Week 12

• Change From Baseline in Quality of Life Per the Short-Form Health Survey (SF-36)

  Baseline to Week 12

Study Arms (2)

AKST1210

EXPERIMENTAL

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

Device: AKST1210; Procedure: Hemodialysis

Sham Control (No Intervention)

SHAM COMPARATOR

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

Other: Sham Control (No Intervention); Procedure: Hemodialysis

Interventions

AKST1210 DEVICE

AKST1210

AKST1210

Sham Control (No Intervention) OTHER

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

Sham Control (No Intervention)

Hemodialysis PROCEDURE

Hemodialysis

AKST1210; Sham Control (No Intervention)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alkahest, Inc.: lead

Study Sites (4)

Renal Consultants Medical Group

Granada Hills, California, 91344, United States

Location

Valley Renal Medical Group

Northridge, California, 91324, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

US Renal Care Kidney Research

San Antonio, Texas, 78251, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Kidney Failure, Chronic; Kidney Diseases; Cognition Disorders

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Renal Insufficiency, Chronic; Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Limitations and Caveats

After the study was closed, unreliable data was identified at a single study site and has not been presented here.

Results Point of Contact

• Title: Head of Communications
• Organization: Alkahest, Inc.

sm-Trials-alkahest@grifols.com

(650) 801-0474

Study Officials

• Alkahest Medical Monitor

  Alkahest, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: August 26, 2020
• Study Start: April 28, 2020
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: December 12, 2022
• Results First Posted: December 12, 2022

Record last verified: 2022-11

Locations

US (4)