Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Monitoring Force Group | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
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:
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Maxence Ficheux, Dr | University Hospital, Caen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Caen | Recruiting | Caen | Normandy | 14000 | France |
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |