Chronic Kidney Disease (CKD) Chronic Kidney Disease
Conditions
Interventions
Neokidney system, not CE marked
Sponsors
Nextkidney SA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adults, aged 18 years or over, stable on HD for 1 month or more according to the investigator.Agree to undergo SFHD (= 4 times 2-hour HD per week) for the duration of the follow-up of the patient in the study.Body weight = 50 kg and = 110 kg.Well-functioning vascular access (native arteriovenous fistula or arteriovenous graft or permanent central veinous catheter) defined as:Capable of providing a blood flow rate of =200 mL/min or a known estimated access recirculation of less than 25%,, AND Absence of vascular access revision for at least 1 month For females of childbearing potential, negative pregnancy test and use of appropriate birth control method(s).Ability to understand the information letter and give written informed consent.Willingness and ability to comply with clinical investigation procedures and to attend all investigation follow-up visits.
Exclusion criteria
Exclusion criteria: Non-Inclusion criteria:Any documented episode of hemolysis within the 4 weeks prior to enrolment.Any infection related to vascular access within the 4 weeks prior to enrolment.History of impaired liver function (i.e., abnormal Factor V).Known chronic obstructive pulmonary disease.Anticipation of a living donor kidney transplantation within the 2 months following inclusion.Pregnant, breast feeding, or planning a pregnancy during the investigation period.Participants: Currently enrolled in another interventional clinical study*, or Previously on-going participation in another interventional clinical study in the last 4 weeks or in the post participation wash-out period of an interventional clinical study, or planning to enroll in another interventional clinical study, Known history of drug and/or alcohol abuse within the last 3 months prior to enrolment.Participants with any serious medical condition* or psychosocial problem which in the opinion of the investigator, may adversely affect the safety of the participant and/or effectiveness of the investigational deviceIncapacitated patients (even in presence of a ‘Legally designated representative’)Exclusion criteria:Criteria for exclusion before the first Neokidney HD session (from blood sample results done at inclusion visit or within a four-week period prior to inclusion):Hemoglobin level <10g/dL (6.2 mmol/L).Pre-dialysis serum sodium concentration <130 mmol/L.Pre-dialysis plasma potassium concentration <3mmol/L or =6.0 mmol/L.Abnormal Liver panel (i.e., ALAT, ASAT, ALP and/or GGT >2x upper limit of reference range, elevated bilirubin at the discretion of the investigator).Pregnant or planning a pregnancy during the investigation period.Severe uncontrolled arterial hypertension (SBP >180 mmHg or DBP >110 mmHg).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the dialysis performance of SFHD carried out with Neokidney, based on the average single pool Kt/V (spKt/V) as calculated of all sessions with SpKt/V data using the Daugirdas Formula, with a lower confidence bound of the two-sided 95% CI = 0.6, after a total of 500 HD sessions have been carried out.To assess the safety of the Neokidney device, amongst others based on the percentage of sessions with Serious Adverse Device Effects (SADE) estimated on 500 and 1000 sessions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Weekly dialysis Standard Kt/V (stdKt/V).Average spKt/V per patient.Total Standard Kt/V (Total Kt/V) (Total Kt/V will be calculated based on the weekly dialytic Kt/V and residual kidney function).Average single pool Kt/V (spKt/V), as estimated over all sessions after a total of 1000 HD sessions have been carried out with spKT/V data using the Daugirdas Formula. (In all above cases, the Daugirdas Formula is used.)The comparison between the post-dialysis patient weight and the target weight.The comparison between the net fluid removal measured by the device and the weight loss measured from patient’s body weight.The ratio of the UF volume measured by the device at the end of the treatment and target UF volume (UF goal) entered in the device.Session characteristics (number/week, duration, blood flow rate, UF volume) in-hospital settings and in autonomous dialysis settings.Evolution of clinical conditions and vital signs (blood pressure, heart rate, body temperature and pulse oximetry) before and after each HD session.Evolution of blood analytes before and after treatment over the study period.Participant satisfaction questionnaire.Changes in Quality of life between inclusion and end of clinical investigation.Changes in Quality of life between in-site sessions and autonomous dialysis setting of Neokidney (Phases 2 and 3). | — |
Countries
Belgium, France, Netherlands
Contacts
Public ContactS. Texier
Monitoring Force France
Outcome results
None listed