Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients (NCT06433193) | Clinical Trial Compass
CompletedNot Applicable
Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients
Singapore3 participantsStarted 2024-02-22
Plain-language 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.
Who can participate
Age range21 Years – 79 Years
SexALL
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Inclusion criteria
✓. Subjects must be adults \>/= 21 years old and \<80 years old.
✓. Subjects must be weighing \>/= 55kg and \<90kg (patient's dry weight).
✓. Subjects must have stable haemoglobin \>/= 10.5g/dL, 2 months prior to enrolment
✓. Subjects' pre-dialysis serum values must be within the following range, 2 months prior to enrolment:
✓. Subjects on stable on thrice weekly 4-h HD schedule. Stability is defined as:
✓. Subjects with a well-functioning vascular access (native fistula graft):
✓. Subjects capable of understanding the informed consent form and give informed consent.
✓. Subjects willing and able to comply with study procedures and to attend all study follow-up visits.
Exclusion criteria
✕. Subjects with haemoglobin level of \<10.5g/dL in any measurement 2 months prior to enrolment.
✕. Subjects with the following pre-dialysis serum values in any measurement 2 months prior to enrolment:
✕. Subjects with severe hypertension: systolic blood pressure \> /=180 mmHg, diastolic blood pressure \>/=120 mmHg in any officemeasurement less than 4 weeks prior to enrolment.
✕. Subjects with chronic obstructive pulmonary disease or any respiratory disease that may predispose to CO2 retention.
What they're measuring
1
The primary objective of this early feasibility clinical trial is to assess the (short term) clinical safety of the PAK HD sorbent treatment in a limited number of patients and treatments.
✕. Subjects with impaired liver function. Impaired liver function is defined as an elevated ALT (alanine aminotransferase) by 3-fold orgreater above the upper limit of normal.
✕. Subjects with episodes of haemolysis in any measurement 3 months prior to enrolment.
✕. Subjects with a central venous catheter.
✕. Subjects with vascular access dysfunction (whether or not requiring an intervention), i.e. failure to achieve and/ or sustain a bloodflow of \>/=250 mL/min and/or signs of compromised vascular access patency (according to the opinion of the investigator) within 4weeks prior to enrolment.