Assessing the safety and efficacy of NeoKidney® for patients with end-stage renal disease on short daily hemodialysis
Safety and Efficacy Assessments of NeoKidney®, a New Sorbent-based Hemodialysis Device, in ESRD Patients Treated With Short Daily Hemodialysis: a First in Human Use.
This study is testing a new device called NeoKidney® to see if it helps people with end-stage kidney disease feel better while they receive short daily hemodialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nextkidney S.A. Industry-sponsored |
| Locations | 1 site (Caen, Normandie) |
| Trial ID | NCT06024135 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates the safety and efficacy of the NeoKidney® device in patients with end-stage renal disease (ESRD) who are undergoing short daily hemodialysis. Participants will progressively use the NeoKidney® device over three weeks, starting with one session in the first week, followed by two sessions in the second week, and then six consecutive days in the third week, with other sessions conducted using their usual home device. The study aims to determine how well the NeoKidney® performs compared to standard treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over who have been on short daily hemodialysis for at least three months.
Not a fit: Patients with a post-dialysis body weight below 41.0 kg or significant anemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a more effective and safer hemodialysis option for ESRD patients.
How similar studies have performed: While similar approaches have been explored, the NeoKidney® device represents a novel intervention in this specific patient population.
Eligibility criteria
Show full inclusion / exclusion 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 \<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. 3. One or more pre-dialysis urea concentration \<10 mmol/L or \>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
Where this trial is running
Caen, Normandie
- CHU de Caen — Caen, Normandie, France (Recruiting)
Study contacts
- Principal investigator: Maxence Ficheux, Dr — University Hospital, Caen
- Study coordinator: Baptiste Juillard
- Email: baptiste.juillard@monitoring-force.fr
- Phone: +33 1 89 81 71 24
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.