safety and efficacy assessments of neokidney® in esrd patients treated with short daily hemodialysis

Conditions: End Stage Renal Disease; ESRD

Summary: the goal of this clinical investigation is to asses the safety and efficacy a new sorbent-based hemodialysis device, neokidney® in esrd patients treated with short daily hemodialysis. participants (stable sdhd patients) will undergo hemodialysis treatement on the neokidney® device at the hospital on a progressive exposition to the device: * the first week, patient will be treated once with neokidney® on wednesday * the 2nd week the patient will be treated two consecutive days with neokidney® (in the middle of the week) * on the 3rd week, after approval by the dsmb, the patients will be treated 6 consecutive days, in hospital, with the neokidney all the other sessions will be performed with the patient's usual sdhd device at home except for two sessions prior to neokidney® sessions at week 1 and 2.


Eligibility criteria:
inclusion criteria: 1. male or female aged 18 years or over; 2. treated with short-daily hemodialysis (1.5-3 h sessions) 5-6 times a week for at least 3 months; 3. estimated urea removal concentration between \[220 to 550\] mmol. (estimation based on the formula: (\[dry weigh in kg\]\*\] x 0,6)\*(\[) x (\[last pre-dialysis urea concentration in mmol/l\]\*\] x 0,5). 4. well-functioning vascular access (native fistula or graft or permanent veinous catheter) defined as: * capable of providing a blood flow rate of ≥200 ml/min, and * absence of vascular access revision for at least 3 months 5. for females of reproducible age, negative urinary pregnancy test and use of appropriate birth control method(s); 6. ability to understand the informed consent and give informed consent; 7. willingness and ability to comply with study procedures and to attend all study follow up visits exclusion criteria: 1. post-dialysis body weight below 41.0 kg 2. hb \ 145 mmol/l, pre-dialysis \[k\] \ 6 mmol/l and pre-dialysis \[hco3\] \ 30 mmol/l in the latest determination, within the 6 weeks prior to enrollment. 3. one or more pre-dialysis urea concentration \ 30mmol/l within the 6 weeks prior to enrollment. 4. subjects requiring uf volume \>2.0l per 2hr treatment in any dialysis session within 6 weeks prior to enrollment. 5. any documented episode of hemolysis within the 6 months prior to enrolment. 6. any infection related to the vascular access within the 4 weeks prior to enrolment. 7. history of impaired liver function (normal factor v). 8. severe uncontrolled arterial hypertension (systolic bp\>180mmhg or diastolic bp \>104 mmhg). 9. known chronic obstructive pulmonary disease. 10. anticipation of a living donor kidney transplantation within the 2 months of the study period. 11. pregnant, breast feeding, or planning a pregnancy during the study period. 13. any known psychosocial problems which may negatively influence dialysis treatment. 14. history of drug and/or alcohol abuse within the last 3 months prior to enrolment. 15. patients with any serious medical condition which in the opinion of the investigator, may adversely affect the safety of the participant and/or effectiveness of the study

Keywords: dialysis hemodialysis sorbent short daily hemodialysis sdhd hd esrd end stage renal disease dialysate