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

Alkahest

Status: Completed

Conditions: Cognitive Impairment; End Stage Renal Disease

Treatments: Device: AKST1210; Other: Sham Control (No Intervention); Procedure: Hemodialysis

Study type: Interventional

Funder types: Industry

Identifiers

NCT04527328

AKST1210-201

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

10 participants in 2 patient groups

AKST1210

Experimental group

Description:

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

Treatment:

Procedure: Hemodialysis

Device: AKST1210

Sham Control (No Intervention)

Sham Comparator group

Description:

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

Treatment:

Procedure: Hemodialysis

Other: Sham Control (No Intervention)