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Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients

End Stage Renal Disease Clinical Trial

Official title:
Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients

Clinical Trial Summary

The primary aim of this early feasibility clinical trial is to assess the biochemical safety of dialysate regeneration with the optimised PAK HDsorbent cartridge in a limited number (n=3) of participants and treatments (one therapy per subject). As a secondary aim, we will assessthe therapy efficacy of the PAK HD sorbent therapy in short-daily hemodialysis (SDHD) and compare it to that of conventional CHD underthe same therapy settings. Following up from the preceding FIH trial, this continuation aims at demonstrating that the optimised PAK HD sorbent system has overcome previous problems of increased dialysate acidity and provides improved control over the patient's acid-base balance.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06433193
Study type Interventional
Source Nextkidney S.A.
Contact
Status Completed
Phase N/A
Start date February 22, 2024
Completion date April 24, 2024
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