xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06024135</url>
    </required_header>
    <id_info>
      <org_study_id>NKH-CI22-01</org_study_id>
      <nct_id>NCT06024135</nct_id>
    </id_info>
    <brief_title>Safety and Efficacy Assessments of NeoKidney® in ESRD Patients Treated With Short Daily Hemodialysis</brief_title>
    <acronym>FIH Caen</acronym>
    <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.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nextkidney S.A.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Monitoring Force Group</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Nextkidney S.A.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical investigation is to asses the safety and efficacy a new&#xD;
        sorbent-based hemodialysis device, NeoKidney® in ESRD patients treated with short daily&#xD;
        hemodialysis.&#xD;
  &#xD;
        Participants (stable SDHD patients) will undergo hemodialysis treatement on the NeoKidney®&#xD;
        device at the hospital on a progressive exposition to the device:&#xD;
  &#xD;
          -  The first week, patient will be treated once with NeoKidney® on Wednesday&#xD;
  &#xD;
          -  The 2nd week the patient will be treated two consecutive days with NeoKidney® (in the&#xD;
             middle of the week)&#xD;
  &#xD;
          -  On the 3rd week, after approval by the DSMB, the patients will be treated 6 consecutive&#xD;
             days, in hospital, with the NeoKidney&#xD;
  &#xD;
        All the other sessions will be performed with the patient's usual SDHD device at home except&#xD;
        for two sessions prior to NeoKidney® sessions at Week 1 and 2.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Absence of serious adverse events (SAE) and of serious adverse device effects (SADE).</measure>
      <time_frame>Through the end of last patient follow-up visit, an average of 2 months</time_frame>
      <description>To assess the safety of the NeoKidney in a small number (n=3) of patients and HD sessions (9 sessions per patient).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of critical change in patient's blood pressure (mm Hg) during treatment</measure>
      <time_frame>Through the end of last patient follow-up visit, an average of 2 months</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of critical change in patient's heart rate (bpm) during treatment</measure>
      <time_frame>Through the end of last patient follow-up visit, an average of 2 months</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of critical change in patient's body temperature (°C) during treatment</measure>
      <time_frame>Through the end of last patient follow-up visit, an average of 2 months</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of critical change in patient's pulse oximetry (% SpO2) during treatment</measure>
      <time_frame>Through the end of last patient follow-up visit, an average of 2 months</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of critical change in bicarbonates (mmol/L) pre- vs post-treatment</measure>
      <time_frame>Through the end of last patient follow-up visit, an average of 2 months</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of critical change in pH pre- vs post-treatment</measure>
      <time_frame>Through the end of last patient follow-up visit, an average of 2 months</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of critical change in LDH (UI/L) pre- vs post-treatment</measure>
      <time_frame>Through the end of last patient follow-up visit, an average of 2 months</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of critical change in Haptoglobin (g/L) pre- vs post-treatment</measure>
      <time_frame>Through the end of last patient follow-up visit, an average of 2 months</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of critical change in Sodium (mmol/L) pre- vs post-treatment</measure>
      <time_frame>Through the end of last patient follow-up visit, an average of 2 months</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of critical change in Potassium (mmol/L) pre- vs post-treatment</measure>
      <time_frame>Through the end of last patient follow-up visit, an average of 2 months</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of critical change in Phosphate (mmol/L) pre- vs post-treatment</measure>
      <time_frame>Through the end of last patient follow-up visit, an average of 2 months</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of critical change in Calcium (mmol/L) pre- vs post-treatment</measure>
      <time_frame>Through the end of last patient follow-up visit, an average of 2 months</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of critical change in Chlorine (mmol/L) pre- vs post-treatment</measure>
      <time_frame>Through the end of last patient follow-up visit, an average of 2 months</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of critical change in Magnesium (mmol/L) pre- vs post-treatment</measure>
      <time_frame>Through the end of last patient follow-up visit, an average of 2 months</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of critical change in Magnesium (µmol/L) pre- vs post-treatment</measure>
      <time_frame>Through the end of last patient follow-up visit, an average of 2 months</time_frame>
      <description>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).</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">3</enrollment>
    <condition>End Stage Renal Disease</condition>
    <condition>ESRD</condition>
    <arm_group>
      <arm_group_label>NeoKidney therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Every patient will receive NeoKidney therapy which will be referenced to SDHD sessions with the usual device as their own baseline.&#xD;
  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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>NeoKidney</intervention_name>
      <description>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.</description>
      <arm_group_label>NeoKidney therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female aged 18 years or over;&#xD;
  &#xD;
            2. Treated with short-daily hemodialysis (1.5-3 h sessions) 5-6 times a week for at least&#xD;
               3 months;&#xD;
  &#xD;
            3. Estimated Urea removal concentration between [220 to 550] mmol. (Estimation based on&#xD;
               the formula: ([Dry Weigh in kg]*] x 0,6)*([) x ([Last pre-dialysis urea concentration&#xD;
               in mmol/L]*] x 0,5).&#xD;
  &#xD;
            4. Well-functioning vascular access (native fistula or graft or permanent veinous&#xD;
               catheter) defined as:&#xD;
  &#xD;
                 -  Capable of providing a blood flow rate of ≥200 mL/min, AND&#xD;
  &#xD;
                 -  Absence of vascular access revision for at least 3 months&#xD;
  &#xD;
            5. For females of reproducible age, negative urinary pregnancy test and use of&#xD;
               appropriate birth control method(s);&#xD;
  &#xD;
            6. Ability to understand the informed consent and give informed consent;&#xD;
  &#xD;
            7. Willingness and ability to comply with study procedures and to attend all study follow&#xD;
               up visits&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Post-dialysis body weight below 41.0 kg&#xD;
  &#xD;
            2. Hb &lt;10.0 g/L, or pre-dialysis [Na] &lt; 132 and &gt; 145 mmol/L, pre-dialysis [K] &lt; 3.5 and&#xD;
               &gt; 6 mmol/L and pre-dialysis [HCO3] &lt; 15 and &gt; 30 mmol/L in the latest determination,&#xD;
               within the 6 weeks prior to enrollment.&#xD;
  &#xD;
            3. One or more pre-dialysis urea concentration &lt;10 mmol/L or &gt;30mmol/L within the 6 weeks&#xD;
               prior to enrollment.&#xD;
  &#xD;
            4. Subjects requiring UF volume &gt;2.0L per 2hr treatment in any dialysis session within 6&#xD;
               weeks prior to enrollment.&#xD;
  &#xD;
            5. Any documented episode of hemolysis within the 6 months prior to enrolment.&#xD;
  &#xD;
            6. Any infection related to the vascular access within the 4 weeks prior to enrolment.&#xD;
  &#xD;
            7. History of impaired liver function (normal Factor V).&#xD;
  &#xD;
            8. Severe uncontrolled arterial hypertension (systolic BP&gt;180mmHg or diastolic BP &gt;104&#xD;
               mmHg).&#xD;
  &#xD;
            9. Known chronic obstructive pulmonary disease.&#xD;
  &#xD;
           10. Anticipation of a living donor kidney transplantation within the 2 months of the study&#xD;
               period.&#xD;
  &#xD;
           11. Pregnant, breast feeding, or planning a pregnancy during the study period.&#xD;
  &#xD;
          13. Any known psychosocial problems which may negatively influence dialysis treatment.&#xD;
  &#xD;
          14. History of drug and/or alcohol abuse within the last 3 months prior to enrolment.&#xD;
  &#xD;
          15. Patients with any serious medical condition which in the opinion of the investigator,&#xD;
          may adversely affect the safety of the participant and/or effectiveness of the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Maxence Ficheux, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Caen</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Baptiste Juillard</last_name>
      <phone>+33 1 89 81 71 24</phone>
      <email>baptiste.juillard@monitoring-force.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Amin Kadi, Dr</last_name>
      <phone>+33 1 89 81 71 24</phone>
      <email>amin.kadi@monitoring-force.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CHU de Caen</name>
        <address>
          <city>Caen</city>
          <state>Normandie</state>
          <zip>14000</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Maxence Ficheux, Dr</last_name>
        <email>ficheux-m@chu-caen.fr</email>
      </contact>
      <investigator>
        <last_name>Maxence Ficheux, Dr</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Patrick Henry, Dr</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Dialysis</keyword>
    <keyword>Hemodialysis</keyword>
    <keyword>Sorbent</keyword>
    <keyword>Short daily hemodialysis</keyword>
    <keyword>SDHD</keyword>
    <keyword>HD</keyword>
    <keyword>ESRD</keyword>
    <keyword>End stage renal disease</keyword>
    <keyword>Dialysate</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Kidney Failure, Chronic</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06024135
  org study id: NKH-CI22-01
  nct id: NCT06024135
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 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
  description: To assess the safety of the NeoKidney in a small number (n=3) of patients and HD sessions (9 sessions per patient).
  measure: 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
  description: 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).
  measure: 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
  description: 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).
  measure: 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
  description: 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).
  measure: 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
  description: 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).
  measure: 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
  description: 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).
  measure: 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
  description: 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).
  measure: 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
  description: 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).
  measure: 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
  description: 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).
  measure: 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
  description: 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).
  measure: 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
  description: 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).
  measure: 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
  description: 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).
  measure: 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
  description: 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).
  measure: 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
  description: 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).
  measure: 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
  description: 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).
  measure: 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
  description: 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).
  arm group label: NeoKidney therapy
  arm group type: Experimental
  description: 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.
  intervention type: Device
  intervention name: NeoKidney
  description: 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.
  arm group label: NeoKidney therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Maxence Ficheux, Dr
  role: Principal Investigator
  affiliation: University Hospital, Caen
  last name: Baptiste Juillard
  phone: +33 1 89 81 71 24
  email: baptiste.juillard@monitoring-force.fr
  last name: Amin Kadi, Dr
  phone: +33 1 89 81 71 24
  email: amin.kadi@monitoring-force.fr
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Kidney Failure, Chronic