NCT04527328

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Alkahest, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cognitive Impairment
• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	AKST1210	AKST1210
OTHER	Sham Control (No Intervention)	A covered surrogate object of similar size and shape as the investigational device
PROCEDURE	Hemodialysis	Hemodialysis

Timeline

• Start date: 2020-04-28
• Primary completion: 2021-06-04
• Completion: 2021-06-04
• First posted: 2020-08-26
• Last updated: 2022-12-12
• Results posted: 2022-12-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study