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

NCT06024135 | Unknown DMC

• 1 other identifier: NKH-CI22-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease; ESRD

Keywords

Dialysis; Hemodialysis; Sorbent; Short daily hemodialysis; SDHD; HD; ESRD; End stage renal disease; Dialysate

Outcome Measures

Primary Outcomes (16)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

NeoKidney therapy

EXPERIMENTAL

Every patient will receive NeoKidney therapy which will be referenced to SDHD sessions with the usual device as their own baseline. The study is designed in a way that allows an incremental increase of the ratio of NeoKidney versus SDHD sessions with the usual device. In order to minimize the study burden to the patient, most SDHD sessions with the usual device will be done in the patient's home. The NeoKidney therapy sessions, and 2 SDHD sessions with the usual device will be performed in the study center, thus ensuring the necessary patient care and observation as well as sample collection.

Device: NeoKidney

Interventions

NeoKidney DEVICE

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.

NeoKidney therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• \. Any known psychosocial problems which may negatively influence dialysis treatment.
• \. History of drug and/or alcohol abuse within the last 3 months prior to enrolment.
• \. 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

Sponsors & Collaborators

• Nextkidney S.A.: lead
• Monitoring Force Group: collaborator

Study Sites (1)

CHU de Caen

Caen, Normandy, 14000, France

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maxence Ficheux, Dr

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baptiste Juillard

CONTACT

+33 1 89 81 71 24; baptiste.juillard@monitoring-force.fr

Amin Kadi, Dr

CONTACT

+33 1 89 81 71 24; amin.kadi@monitoring-force.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: September 6, 2023
• Study Start: March 11, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 21, 2024

Record last verified: 2023-08

Locations

FR (1)