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

NACompletedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

February 22, 2024

Primary Completion Date

April 24, 2024

Study Completion Date

April 24, 2024

Conditions
End Stage Renal DiseaseESRD
Interventions
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."

Trial Locations (1)

119074

National University Hospital Investigational Medicine Unit, Singapore

All Listed Sponsors
lead

Nextkidney S.A.

INDUSTRY

NCT06433193 - Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients | Biotech Hunter | Biotech Hunter