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

End Stage Renal Disease Clinical Trial

— FIH Caen  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06024135
• Other study ID #: NKH-CI22-01
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Nextkidney S.A.
• Contact: Baptiste Juillard
• Phone: +33 1 89 81 71 24
• Email: baptiste.juillard[@]monitoring-force.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• ESRD
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Caen	Caen	Normandie

Sponsors (2)

Lead Sponsor	Collaborator
Nextkidney S.A.	Monitoring Force Group

Country where clinical trial is conducted

France, 

Outcome

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