N/A
Completed N=10
A Study to Assess the Tolerability and Efficacy of AKST1210 in Patients on Hemodialysis With Cognitive Impairment
Source: ClinicalTrials.gov NCT04527328 ↗Enrolled (actual)
10
Serious AEs
20.0%
Results posted
Dec 2022
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events Assessed by Intensity — 0; 1; 2; 2 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events Assessed by Intensity |
0; 1; 2; 2; 2; 0 | — |
| SECONDARY Tolerability as Measured by the Number of Subjects Who Complete Each Treatment Period |
5; 5; 3; 5 | — |
| SECONDARY Number of Participants Who Discontinued Due to Intradialytic Hypotension (IDH) |
1; 0 | — |
| SECONDARY Change From Baseline in Montreal Cognitive Assessment (MoCA) |
1.0; 0.6; 0.5; -0.2; 0.5; 0.0 | — |
| SECONDARY Change From Baseline in Computer-based Cognitive Assessment (CogState) Composite Score |
-0.1; 0.4; -0.2; 0.5; 0.0; 0.6 | — |
| SECONDARY Change From Baseline in Quality of Life Per the Short-Form Health Survey (SF-36) |
-9.6; -3.4; 0.7; 4.1 | — |
| SECONDARY Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9) |
3.5; -1.2 | — |
| SECONDARY Change From Baseline in Sleep Quality Per the Pittsburgh Sleep Quality Index (PSQI) |
0.0; 0.8; 0.3; 0.2; -0.3; 0.2 | — |
| SECONDARY Change From Baseline in Fatigue Per the Fatigue Questionnaire - Functional Assessments of Chronic Illness Therapy (FACIT) |
-0.5; 0.2 | — |
| SECONDARY Number of Participants Who Discontinued Due to Anemia. |
0; 0 | — |
| SECONDARY Tolerability as Measured by the Percentage of Subjects Who Complete Each Treatment Period |
100.00; 100.00; 75.00; 100.00 | — |
| SECONDARY Tolerability as Measured by the Number of Subjects Who Complete the Run-In Period. |
10 | — |
| SECONDARY Tolerability as Measured by the Percentage of Subjects Who Complete the Run-in Period |
90.9 | — |
| SECONDARY Tolerability as Measured by the Number of Subjects Who Completed All Visits. |
5; 5; 3; 5 | — |
| SECONDARY Tolerability as Measured by the Percentage of Subjects Who Completed All Visits. |
100.00; 100.00; 75.00; 100.00 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04527328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.