Back to resultsSafety and Efficacy Assessments of NeoKidney® in ESRD Patients Treated With Short Daily Hemodialysis (FIH Caen)
Primary Purpose
End Stage Renal Disease, ESRD
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NeoKidney
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring Dialysis, Hemodialysis, Sorbent, Short daily hemodialysis, SDHD, HD, ESRD, End stage renal disease, Dialysate
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. 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
Sites / Locations
- CHU de Caen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NeoKidney therapy
Arm 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.
Outcomes
Primary Outcome Measures
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT06024135
First Posted
August 16, 2023
Last Updated
August 28, 2023
Sponsor
Nextkidney S.A.
Collaborators
Monitoring Force Group
1. Study Identification
Unique Protocol Identification Number
NCT06024135
Brief Title
Safety and Efficacy Assessments of NeoKidney® in ESRD Patients Treated With Short Daily Hemodialysis
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nextkidney S.A.
Collaborators
Monitoring Force Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, ESRD
Keywords
Dialysis, Hemodialysis, Sorbent, Short daily hemodialysis, SDHD, HD, ESRD, End stage renal disease, Dialysate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NeoKidney therapy
Arm Type
Experimental
Arm 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(s)
NeoKidney
Intervention 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.
Primary Outcome Measure Information:
Title
Absence of serious adverse events (SAE) and of serious adverse device effects (SADE).
Description
To assess the safety of the NeoKidney in a small number (n=3) of patients and HD sessions (9 sessions per patient).
Time Frame
Through the end of last patient follow-up visit, an average of 2 months
Title
Absence of critical change in patient's blood pressure (mm Hg) during treatment
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).
Time Frame
Through the end of last patient follow-up visit, an average of 2 months
Title
Absence of critical change in patient's heart rate (bpm) during treatment
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).
Time Frame
Through the end of last patient follow-up visit, an average of 2 months
Title
Absence of critical change in patient's body temperature (°C) during treatment
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).
Time Frame
Through the end of last patient follow-up visit, an average of 2 months
Title
Absence of critical change in patient's pulse oximetry (% SpO2) during treatment
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).
Time Frame
Through the end of last patient follow-up visit, an average of 2 months
Title
Absence of critical change in bicarbonates (mmol/L) pre- vs post-treatment
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).
Time Frame
Through the end of last patient follow-up visit, an average of 2 months
Title
Absence of critical change in pH pre- vs post-treatment
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).
Time Frame
Through the end of last patient follow-up visit, an average of 2 months
Title
Absence of critical change in LDH (UI/L) pre- vs post-treatment
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).
Time Frame
Through the end of last patient follow-up visit, an average of 2 months
Title
Absence of critical change in Haptoglobin (g/L) pre- vs post-treatment
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).
Time Frame
Through the end of last patient follow-up visit, an average of 2 months
Title
Absence of critical change in Sodium (mmol/L) pre- vs post-treatment
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).
Time Frame
Through the end of last patient follow-up visit, an average of 2 months
Title
Absence of critical change in Potassium (mmol/L) pre- vs post-treatment
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).
Time Frame
Through the end of last patient follow-up visit, an average of 2 months
Title
Absence of critical change in Phosphate (mmol/L) pre- vs post-treatment
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).
Time Frame
Through the end of last patient follow-up visit, an average of 2 months
Title
Absence of critical change in Calcium (mmol/L) pre- vs post-treatment
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).
Time Frame
Through the end of last patient follow-up visit, an average of 2 months
Title
Absence of critical change in Chlorine (mmol/L) pre- vs post-treatment
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).
Time Frame
Through the end of last patient follow-up visit, an average of 2 months
Title
Absence of critical change in Magnesium (mmol/L) pre- vs post-treatment
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).
Time Frame
Through the end of last patient follow-up visit, an average of 2 months
Title
Absence of critical change in Magnesium (µmol/L) pre- vs post-treatment
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).
Time Frame
Through the end of last patient follow-up visit, an average of 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baptiste Juillard
Phone
+33 1 89 81 71 24
Email
baptiste.juillard@monitoring-force.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Amin Kadi, Dr
Phone
+33 1 89 81 71 24
Email
amin.kadi@monitoring-force.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maxence Ficheux, Dr
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Caen
City
Caen
State/Province
Normandie
ZIP/Postal Code
14000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxence Ficheux, Dr
Email
ficheux-m@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Maxence Ficheux, Dr
First Name & Middle Initial & Last Name & Degree
Patrick Henry, Dr
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Assessments of NeoKidney® in ESRD Patients Treated With Short Daily Hemodialysis
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