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

A Randomized, Double-Blind, Phase 2a Study to Evaluate the Tolerability, Feasibility, and Efficacy of AKST1210 in Patients on Hemodialysis With Cognitive Impairment Associated With End-Stage Renal Disease

Sponsors

Lead Sponsor: Alkahest, Inc.

Source Alkahest, Inc.
Brief Summary

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

Detailed 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.

Overall Status Recruiting
Start Date April 28, 2020
Completion Date December 31, 2020
Primary Completion Date December 31, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Safety of AKST1210 as evaluated by the incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Baseline to Week 12
Secondary Outcome
Measure Time Frame
Tolerability as measured by the number of subjects who complete each treatment period. Baseline to Week 12
Tolerability as measured by the percentage of subjects who complete each treatment period. Baseline to Week 12
Tolerability as measured by the number of subjects who complete the run-in period. Screening to Week 1
Tolerability as measured by the percentage of subjects who complete the run-in period. Screening to Week 1
Tolerability as measured by the number of subjects who completed all visits. Baseline to Week 12
Tolerability as measured by the percentage of subjects who completed all visits. Baseline to Week 12
The incidence of discontinuation due to Intradialytic Hypotension (IDH). Baseline to Week 12
The incidence of discontinuation due to anemia. Baseline to Week 12
Change from baseline in Montreal Cognitive Assessment (MoCA) Baseline to Week 12
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
Change from baseline in the Patient Health Questionnaire-9 (PHQ-9) Baseline to Week 12
Change from baseline in sleep quality per the Pittsburgh Sleep Quality Index (PSQI) Baseline to Week 12
Change from baseline in fatigue per the Fatigue Questionnaire - Functional Assessments of Chronic Illness Therapy (FACIT) Baseline to Week 12
Enrollment 26
Condition
Intervention

Intervention Type: Device

Intervention Name: AKST1210

Description: AKST1210 apheresis column

Arm Group Label: AKST1210 apheresis device

Intervention Type: Device

Intervention Name: Control

Description: Control object to mimic column

Arm Group Label: Control column

Intervention Type: Procedure

Intervention Name: Hemodialysis

Description: Hemodialysis

Arm Group Label: AKST1210 apheresis device

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 40 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Alkahest Clinical Trials

Phone: 650-801-0474

Email: [email protected]

Location
Facility: Status: Contact:
Renal Consultants Medical Group | Granada Hills, California, 91344, United States Recruiting Kamal Gandhi, MD 818-366-4632 [email protected]
Valley Renal Medical Group | Northridge, California, 91324, United States Recruiting Jesse Padilla 818-350-5053 [email protected]
Orlando Clinical Research Center | Orlando, Florida, 32809, United States Recruiting Thomas C. Marbury, MD 407-240-7878 [email protected]
US Renal Care Kidney Research | San Antonio, Texas, 78251, United States Recruiting Lisa Rios, CMA, CRC 210-521-5923 [email protected]
Location Countries

United States

Verification Date

February 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: AKST1210 apheresis device

Type: Experimental

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

Label: Control column

Type: Placebo Comparator

Description: A sham control with no effect on the dialyzed blood will be used.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov