Safety and Efficacy Assessments of NeoKidney® in ESRD Patients Treated With Short Daily Hemodialysis (FIH Caen)

March 19, 2024 updated by: Nextkidney S.A.

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
    • Normandie
      • Caen, Normandie, France, 14000
        • Recruiting
        • CHU de Caen
        • Contact:
        • Principal Investigator:
          • Maxence Ficheux, Dr
        • Sub-Investigator:
          • Patrick Henry, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NeoKidney therapy

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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Absence of serious adverse events (SAE) and of serious adverse device effects (SADE).
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
Through the end of last patient follow-up visit, an average of 2 months
Absence of critical change in pH pre- vs post-treatment
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
Through the end of last patient follow-up visit, an average of 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nextkidney S.A.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Monitoring Force Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maxence Ficheux, Dr, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NKH-CI22-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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