Status:
COMPLETED
A Study to Assess the Tolerability and Efficacy of AKST1210 in Patients on Hemodialysis With Cognitive Impairment
Lead Sponsor:
Alkahest, Inc.
Conditions:
Cognitive Impairment
End Stage Renal Disease
Eligibility:
All Genders
40+ years
Phase:
NA
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...
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 hemodial...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04527328
Start Date
April 28 2020
End Date
June 4 2021
Last Update
December 12 2022
Active Locations (4)
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1
Renal Consultants Medical Group
Granada Hills, California, United States, 91344
2
Valley Renal Medical Group
Northridge, California, United States, 91324
3
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
4
US Renal Care Kidney Research
San Antonio, Texas, United States, 78251