Status:
UNKNOWN
Safety and Efficacy Assessments of NeoKidney® in ESRD Patients Treated With Short Daily Hemodialysis
Lead Sponsor:
Nextkidney S.A.
Collaborating Sponsors:
Monitoring Force Group
Conditions:
End Stage Renal Disease
ESRD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 (s...
Eligibility Criteria
Inclusion
- Male or female aged 18 years or over;
- Treated with short-daily hemodialysis (1.5-3 h sessions) 5-6 times a week for at least 3 months;
- 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).
- 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
- For females of reproducible age, negative urinary pregnancy test and use of appropriate birth control method(s);
- Ability to understand the informed consent and give informed consent;
- Willingness and ability to comply with study procedures and to attend all study follow up visits
Exclusion
- Post-dialysis body weight below 41.0 kg
- Hb \<10.0 g/L, or pre-dialysis \[Na\] \< 132 and \> 145 mmol/L, pre-dialysis \[K\] \< 3.5 and \> 6 mmol/L and pre-dialysis \[HCO3\] \< 15 and \> 30 mmol/L in the latest determination, within the 6 weeks prior to enrollment.
- One or more pre-dialysis urea concentration \<10 mmol/L or \>30mmol/L within the 6 weeks prior to enrollment.
- Subjects requiring UF volume \>2.0L per 2hr treatment in any dialysis session within 6 weeks prior to enrollment.
- Any documented episode of hemolysis within the 6 months prior to enrolment.
- Any infection related to the vascular access within the 4 weeks prior to enrolment.
- History of impaired liver function (normal Factor V).
- Severe uncontrolled arterial hypertension (systolic BP\>180mmHg or diastolic BP \>104 mmHg).
- Known chronic obstructive pulmonary disease.
- Anticipation of a living donor kidney transplantation within the 2 months of the study period.
- 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
Key Trial Info
Start Date :
March 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT06024135
Start Date
March 11 2024
End Date
June 1 2024
Last Update
March 21 2024
Active Locations (1)
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1
CHU de Caen
Caen, Normandy, France, 14000