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

Not Applicable

Recruiting

• Conditions: End Stage Renal Disease; ESRD

• Registration Number: NCT06024135
• Lead Sponsor: Nextkidney S.A.

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 (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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-09-06
• Study Start: 2024-03-11
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3

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.

12. Any known psychosocial problems which may negatively influence dialysis treatment.

13. History of drug and/or alcohol abuse within the last 3 months prior to enrolment.

14. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Absence of serious adverse events (SAE) and of serious adverse device effects (SADE).	Through the end of last patient follow-up visit, an average of 2 months	To assess the safety of the NeoKidney in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Absence of critical change in patient's heart rate (bpm) during treatment	Through the end of last patient follow-up visit, an average of 2 months	To assess the safety of the NeoKidney on patient's clinical condition and vital parameters, in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Absence of critical change in Magnesium (µmol/L) pre- vs post-treatment	Through the end of last patient follow-up visit, an average of 2 months	To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Absence of critical change in patient's blood pressure (mm Hg) during treatment	Through the end of last patient follow-up visit, an average of 2 months	To assess the safety of the NeoKidney on patient's clinical condition and vital parameters, in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Absence of critical change in bicarbonates (mmol/L) pre- vs post-treatment	Through the end of last patient follow-up visit, an average of 2 months	To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Absence of critical change in pH pre- vs post-treatment	Through the end of last patient follow-up visit, an average of 2 months	To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Absence of critical change in Haptoglobin (g/L) pre- vs post-treatment	Through the end of last patient follow-up visit, an average of 2 months	To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Absence of critical change in patient's body temperature (°C) during treatment	Through the end of last patient follow-up visit, an average of 2 months	To assess the safety of the NeoKidney on patient's clinical condition and vital parameters, in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Absence of critical change in LDH (UI/L) pre- vs post-treatment	Through the end of last patient follow-up visit, an average of 2 months	To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Absence of critical change in patient's pulse oximetry (% SpO2) during treatment	Through the end of last patient follow-up visit, an average of 2 months	To assess the safety of the NeoKidney on patient's clinical condition and vital parameters, in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Absence of critical change in Sodium (mmol/L) pre- vs post-treatment	Through the end of last patient follow-up visit, an average of 2 months	To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Absence of critical change in Potassium (mmol/L) pre- vs post-treatment	Through the end of last patient follow-up visit, an average of 2 months	To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Absence of critical change in Chlorine (mmol/L) pre- vs post-treatment	Through the end of last patient follow-up visit, an average of 2 months	To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Absence of critical change in Phosphate (mmol/L) pre- vs post-treatment	Through the end of last patient follow-up visit, an average of 2 months	To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Absence of critical change in Magnesium (mmol/L) pre- vs post-treatment	Through the end of last patient follow-up visit, an average of 2 months	To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Absence of critical change in Calcium (mmol/L) pre- vs post-treatment	Through the end of last patient follow-up visit, an average of 2 months	To assess the safety of the NeoKidney on hematology and clinical chemistry pre- vs post-treatment in a small number (n=3) of patients and HD sessions (9 sessions per patient).

Trial Locations

Locations (1)

CHU de Caen; 🇫🇷 Caen, Normandie, France