Clinical trial NCT04527328: A Study to Assess the Tolerability and Efficacy of AKST1210 in Patients on Hemodialysis With Cognitive Impairment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Alkahest, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-26
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events Assessed by Intensity
timeFrame: Baseline to Week 14
Secondary outcomes:
measure: Tolerability as Measured by the Number of Subjects Who Complete Each Treatment Period
timeFrame: Baseline to Week 12
measure: Number of Participants Who Discontinued Due to Intradialytic Hypotension (IDH)
timeFrame: Baseline to Week 12
measure: Change From Baseline in Montreal Cognitive Assessment (MoCA)
timeFrame: Screening to Week 14
measure: Change From Baseline in Computer-based Cognitive Assessment (CogState) Composite Score
timeFrame: Baseline to Week 12
measure: Change From Baseline in Quality of Life Per the Short-Form Health Survey (SF-36)
timeFrame: Baseline to Week 12
measure: Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline to Week 14
measure: Change From Baseline in Sleep Quality Per the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline to Week 12
measure: Change From Baseline in Fatigue Per the Fatigue Questionnaire - Functional Assessments of Chronic Illness Therapy (FACIT)
timeFrame: Baseline to Week 12
measure: Number of Participants Who Discontinued Due to Anemia.
timeFrame: Baseline to Week 12
measure: Tolerability as Measured by the Percentage of Subjects Who Complete Each Treatment Period
timeFrame: Baseline to Week 12
measure: Tolerability as Measured by the Number of Subjects Who Complete the Run-In Period.
timeFrame: Week -2 (Day -14) to Week -1 (Day -1)
measure: Tolerability as Measured by the Percentage of Subjects Who Complete the Run-in Period
timeFrame: Week -2 (Day -14) to Week -1 (Day -1)
measure: Tolerability as Measured by the Number of Subjects Who Completed All Visits.
timeFrame: Baseline to Week 14
measure: Tolerability as Measured by the Percentage of Subjects Who Completed All Visits.
timeFrame: Baseline to Week 14
Other outcomes:
Locations:
city: Granada Hills
country: United States
facility: Renal Consultants Medical Group
state: California
city: Northridge
country: United States
facility: Valley Renal Medical Group
state: California
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: San Antonio
country: United States
facility: US Renal Care Kidney Research
state: Texas
Study officials:
affiliation: Alkahest, Inc.
name: Alkahest Medical Monitor
role: STUDY_DIRECTOR
References: