NCT04985383

Study to Compare Safety and Tolerability of AKST1210 Column at 2 Blood Flow Rates in Subjects With ESRD on Hemodialysis

An Open Label Phase 1 Study to Compare the Safety and Tolerability of the AKST1210 Column at Different Blood-Flow Rates in Patients With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis (HD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Alkahest, Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety and tolerability of the AKST1210 column at blood-flow rates greater than 250 mL/min in subjects with end-stage renal disease (ESRD) undergoing hemodialysis (HD). The study will assess the safety, tolerability, and impact on HD parameters when the AKST1210 column is used at a blood-flow of up to 450 mL/min.

Detailed description

This is an open-label study in approximately 12 to 15 subjects between 40 and 75 years of age with ESRD on HD. The objective of this study is to explore the safety and tolerability of the AKST1210 column at blood-flow rates greater than 250 mL/min in subjects with ESRD undergoing HD. The proposed study will assess the safety, tolerability, and impact on HD parameters when the AKST1210 column is used at a blood-flow rates of up to 450 mL/min. Each participant, per the protocol, will be sequentially treated to each column and blood-flow rate combination. The incidence of IDH events will be one factor used to determine column size/blood-flow rate escalation/de-escalation as well as discontinuation from the study. The planned duration of subject participation is approximately 12 weeks.

Conditions

• End-Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	AKST1210 S-15 at 250 mL/min	Procedure: Hemodialysis, AKST1210 column size 150mL and blood-flow rate at 250mL/min
DEVICE	AKST1210 S-15 at 450 mL/min	Procedure: Hemodialysis, AKST1210 column size 150mL and blood-flow rate at 450mL/min
DEVICE	AKST1210 S-25 at 250 mL/min	Procedure: Hemodialysis, AKST1210 column size 250mL and blood-flow rate at 250mL/min
DEVICE	AKST1210 S-25 at 450 mL/min	Procedure: Hemodialysis, AKST1210 column size 250mL and blood-flow rate at 450mL/min
DEVICE	AKST1210 S-35 at 250 mL/min	Procedure: Hemodialysis, AKST1210 column size 350mL and blood-flow rate at 250mL/min
DEVICE	AKST1210 S-35 at 450 mL/min	Procedure: Hemodialysis, AKST1210 column size 350mL and blood-flow rate at 450mL/min

Timeline

• Start date: 2021-03-11
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2021-08-02
• Last updated: 2023-09-29
• Results posted: 2023-09-29

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study