A Study to Assess the Tolerability and Efficacy of AKST1210 in Patients on Hemodialysis With Cogn… (NCT04527328) | Clinical Trial Compass
CompletedNot Applicable
A Study to Assess the Tolerability and Efficacy of AKST1210 in Patients on Hemodialysis With Cognitive Impairment
United States10 participantsStarted 2020-04-28
Plain-language 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.
Who can participate
Age range40 Years
SexALL
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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…
What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events Assessed by Intensity