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NCT06024135

Safety and Efficacy Assessments of NeoKidney® in ESRD Patients Treated With Short Daily Hemodialysis

Sponsor: Nextkidney S.A.

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-03-11

Completion Date

2024-07-23

Last Updated

2026-10-30

Healthy Volunteers

Conditions

End Stage Renal Disease ESRD

Interventions

DEVICE

NeoKidney

Progressive exposition to NeoKidney device starting with only one NeoKidney therapy on a mid-week day and 5 SDHD sessions with the usual device in week one, followed by 2 NeoKidney therapies and 4 SDHD sessions with the usual device in week 2, and only progressing to a full week on NeoKidney after a safety review.

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

Locations (1)

CHU de Caen

Caen, Normandy, France