NCT06433193

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Nextkidney S.A. · Industry
• Sex: All
• Age: 21 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the safety of dialysate regeneration of the PAK HD sorbent cartridge and therapy efficacy of the PAK HD sorbent therapy compared with conventional hemodialysis.

Detailed description

This clinical trial is being conducted to evaluate the biochemical safety of dialysate regeneration with the PAK HD sorbent cartridge in a limited number of patients and treatments. Therapy efficacy of the PAK HD sorbent therapy will be compared to conventional hemodialysis under the same therapy settings. The trial will use only one single PAK HD sorbent therapy per patient, and a total of 3 patients. The PAK HD therapies will be performed in the middle of the week.

Conditions

• End Stage Renal Disease
• ESRD

Interventions

Type	Name	Description
DEVICE	PAK HD Sorbent Therapy	Study Period 1: Subjects will receive their normal prescribed 4h CHD treatments Monday or Tuesday. On Wednesday or Thursday, one 4h CHD therapy will be performed at a dialysate flow rate (QD) of 300mL/min, identical to the dialysate flow rate of the PAK HD sorbent therapy. Blood and dialysate samples will be collected during treatment and sent for analysis, for comparison with PAK HD sorbent treatment. Study Period 2: Subjects will again receive their normal prescribed 4h CHD treatments Monday or Tuesday. On Wednesday or Thursday, a 2h PAK HD +/- 2h CHD therapy will be performed. Blood and dialysate samples will again be collected during treatment and sent for analysis, for comparison with the CHD therapy of the first period. After completion of study period 2 (PAK HD +/- CHD), subjects will be observed for a minimum duration of 1 h in the hospital after which they may go home if the post-dialysis period was uneventful.

Timeline

• Start date: 2024-02-22
• Primary completion: 2024-04-24
• Completion: 2024-04-24
• First posted: 2024-05-29
• Last updated: 2025-04-01

Locations

1 site across 1 country: Singapore