Chronic Kidney Disease Stage 5NCT04808011
A Single Arm, Multi-Center Study To Evaluate The Intelligent Dialysis Assistant (IDA)
A study testing Intelligent Dialysis Assistant (IDA) in people with Chronic Kidney Disease Stage 5, run by liberDi Ltd. at 3 sites in Israel.
Trial summary
This is a multi-center, open label, cross-over clinical study. A total of 18 subjects will be enrolled to use the IDA for every peritoneal dialysis exchange for 14 days. To participate in the study, the subjects must have current CKD5 and have been treated with PD for at least 3 months. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Kidney Disease Stage 5
- What is being tested?
- Intelligent Dialysis Assistant (IDA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesIsrael
- Study dates
- 22 Dec 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with CKD stage 5 treated by continuous ambulatory peritoneal dialysis (CAPD)
- Male or female, Age >18 years
- Mental ability to understand study procedures and provide an informed consent
- More than 3 months on PD (Peritoneal Dialysis)
- At least 3 daily exchanges
- Self-treated subject
- Stable PD prescription for the last month
Who cannot join
- Need of cycler (APD, Automated Peritoneal Dialysis)
- Known mechanical problem (drainage, fill) during the last month prior to enrollment
- Pregnant or breastfeeding women
- subject who is unwilling or unable to comply with study procedures
- Known Peritonitis or other catheter associated infections during the last 3 months prior to enrollment
- Known Congestive heart failure stage III- IV
Show all 9Show fewer
- Non-elective hospitalization during the last 3 months prior to enrollment
- Any other medical or mental condition, that at the investigator's discretion may prevent the subject from participating in the study
- Participation in any other clinical study within 4 weeks prior to enrollment
Trial locations and contacts
3 sites in 1 country.
Israel3 sites, 3 recruiting
- Recruiting
Soroka Medical Center
Beersheba
Marina Vorobiov, MD, 08-6400373, marinavo@clalit.org.il
- Recruiting
Carmel MC
Haifa
Moran Zaken, Mrs.
Tatiana Tansyochuk, MD
- Recruiting
Meir Medical Center
Kfar Saba
Yael Einbinder, MD
Yael Einbinder, MD
About this study
Official title: A Single Arm, Prospective, Open Label, Cross-Over, Multi-Center Study to Evaluate the Safety, Feasability and Usability of the Intelligent Dialysis Assistant (IDA)
This is a multi-center, open label, cross-over clinical study. A total of 18 subjects will be enrolled to use the IDA for every peritoneal dialysis exchange for 14 days. To participate in the study, the subjects must have current CKD5 and have been treated with PD for at least 3 months. The subjects will undergo a single peritoneal dialysis exchange procedure at the PD clinic, under supervision of the medical staff and instructed about its operation. Further exchanges will be performed by the subjects themselves at home.
The study includes three periods:
- First period (Observational): 14-day Observational Period. Eligible subjects who sign informed consent will continue with their regular CAPD treatment while performing measurement and recording of dialysate in/out time.
- Second period (Interventional): 14-day interventional period, where subjects will perform dialysis exchanges using the IDA according to the below visit schedule.
- Third period (Follow up): 14-day follow up period, during which the study staff will call the subject once weekly to inquire about device-related SAEs and any changes to concomitant medications.
Read the detailed description
This is a multi-center, open label, cross-over clinical study. A total of 20 subjects will be enrolled to use the IDA for every peritoneal dialysis exchange for 14 days. To participate in the study, the subjects must have current CKD5 and have been treated with PD for at least 3 months. The subjects will undergo a single peritoneal dialysis exchange procedure at the PD clinic, under supervision of the medical staff and instructed about its operation. Further exchanges will be performed by the subjects themselves at home.
The study includes two cohorts and two phases: in the first phase (phase I), 20 subjects will be recruited as Cohort 1 to undergo a single exchange in the medical center using the IDA. Following the completion of recruitment of all 20 subjects and the performance of the single on site exchange, the Sponsor will perform an interim analysis of the results for safety and initial feasibility, followed by submission of the results to the MoH and approval of the second phase (phase II). The expected timeframe between phase I and phase II is up to 4 weeks. An additional cohort, Cohort 2, will be added to Phase I, which will include additional ten (10) subjects. These subjects will undergo the same procedure at the dialysis clinic, with the addition of blood sampling for CBC and Chemistry two (2) hours ±30 minutes after the procedure. A total of 20 subjects from either cohort, meeting the inclusion and exclusion criteria of Cohort 1, will continue to complete the second phase of the study (Phase II).
Phase II of the study includes three periods:
First period (Observational): 14-day Observational Period. Eligible subjects who sign informed consent will continue with their regular CAPD treatment while performing measurement and recording of dialysate in/out time.
Second period (Interventional): 14-day interventional period, where subjects will perform dialysis exchanges using the IDA according to the below visit schedule.
Third period (Follow up): 14-day follow up period, during which the study staff will call the subject once weekly to inquire about device-related SAEs and any changes to concomitant medications.
- Conditions
- Chronic Kidney Disease Stage 5
- Being tested
- Intelligent Dialysis Assistant (IDA)
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent Dialysis Assistant (IDA)Device
The IDA is intended for home dialysis for subjects who are stage 5 kidney diease patients and who perform Peritoneal Dialysis. The system is used deveral times a day for approximately 20 minutes for each cycle. During the interventional period, subjects will use only the investigational IDA system for their in/out exchanges.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Each subjects will be treated with his prescribed dialysis device for 14 days, followed by a treatment period of 30 days with the investigational IDA system, and concluding with additional 14 days of treatment with the prescribed dialysis device. Receives: Device: Intelligent Dialysis Assistant (IDA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-Related Serious Adverse Event Incidence
Incidence of device-related SAEs throughout the active investigational phase (14 days).
Measured: 14 days
AE during on site exchange
Incidence of device-related adverse events during the on-site exchange - phase I of the study.
Measured: 1 day
Secondary outcomes (4)
Procedure Time Length
Time length of the in/out PD exchange procedure.
Measured: 14 days
Usability Questionnaire
completion of a Usability questionnaire, designed by the Sponsor, which reflects the physician's impression by the device usage. The questionnaire consists of 4 questions devided to "yes/no" sub-questions.
Measured: 14 days
Device-Related Serious Adverse Events Incidence During Follow Up Period
Incidence of device-related SAEs during the additional 14-day follow up period
Measured: 14 days
Renal Treatment Internal Questionnaire
Analysis of the subject's treatment feedback and effect on quality of life, provided to him/her by using the device. The questionnaire consists of 6 questions ranked from 1 (very dissatisfied) to 5 (very satisfied). The Total Score will be calculated for this questionnaire, with a range of 6-30. A score above 18 will be considered "satisfied".
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start22 Dec 2021
- Primary completion22 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 5Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The subjects will undergo a single peritoneal dialysis exchange procedure at the PD clinic, under the supervision of the medical staff and instructed about its operation. Further exchanges will be performed by the subjects themselves at home. The study includes two cohorts and two phases: in the first phase (phase I), 20 subjects will be recruited as Cohort 1 to undergo a single exchange in the medical center using the IDA. Following the completion of recruitment of all 20 subjects and the performance of the single on site exchange, the Sponsor will perform an interim analysis of the results for safety and initial feasibility, followed by submission of the results to the MoH and approval of the second phase (phase II). Subjects will be treated with their routine dialysis device for 14 days, followed by a treatment with the IDA for a period of 30 days, and then an additional period of 14 days of treatment with their routine dialysis device.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- liberDi Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tatiana Tansyochuk, MD, Principal investigator, Carmel MC, Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808011
- Sponsor's protocol ID
- CSP-028-20
- Status last verified
- Nov 2022
- First submitted
- 1 Mar 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Prospective, Open Label, Cross-Over, Multi-Center Study to Evaluate the Safety, Feasability and Usability of the Intelligent Dialysis Assistant (IDA)
- ClinicalTrials.gov ID
- NCT04808011
- Acronym / sponsor ID
- CSP-028-20
- Conditions
- Chronic Kidney Disease Stage 5
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- liberDi Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 22 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, open label, cross-over clinical study. A total of 18 subjects will be enrolled to use the IDA for every peritoneal dialysis exchange for 14 days. To participate in the study, the subjects must have current CKD5 and have been treated with PD for at least 3 months. The subjects will undergo a single peritoneal dialysis exchange procedure at the PD clinic, under supervision of the medical staff and instructed about its operation. Further exchanges will be performed by the subjects themselves at home.
The study includes three periods:
- First period (Observational): 14-day Observational Period. Eligible subjects who sign informed consent will continue with their regular CAPD treatment while performing measurement and recording of dialysate in/out time.
- Second period (Interventional): 14-day interventional period, where subjects will perform dialysis exchanges using the IDA according to the below visit schedule.
- Third period (Follow up): 14-day follow up period, during which the study staff will call the subject once weekly to inquire about device-related SAEs and any changes to concomitant medications.
Detailed description
This is a multi-center, open label, cross-over clinical study. A total of 20 subjects will be enrolled to use the IDA for every peritoneal dialysis exchange for 14 days. To participate in the study, the subjects must have current CKD5 and have been treated with PD for at least 3 months. The subjects will undergo a single peritoneal dialysis exchange procedure at the PD clinic, under supervision of the medical staff and instructed about its operation. Further exchanges will be performed by the subjects themselves at home.
The study includes two cohorts and two phases: in the first phase (phase I), 20 subjects will be recruited as Cohort 1 to undergo a single exchange in the medical center using the IDA. Following the completion of recruitment of all 20 subjects and the performance of the single on site exchange, the Sponsor will perform an interim analysis of the results for safety and initial feasibility, followed by submission of the results to the MoH and approval of the second phase (phase II). The expected timeframe between phase I and phase II is up to 4 weeks. An additional cohort, Cohort 2, will be added to Phase I, which will include additional ten (10) subjects. These subjects will undergo the same procedure at the dialysis clinic, with the addition of blood sampling for CBC and Chemistry two (2) hours ±30 minutes after the procedure. A total of 20 subjects from either cohort, meeting the inclusion and exclusion criteria of Cohort 1, will continue to complete the second phase of the study (Phase II).
Phase II of the study includes three periods:
First period (Observational): 14-day Observational Period. Eligible subjects who sign informed consent will continue with their regular CAPD treatment while performing measurement and recording of dialysate in/out time.
Second period (Interventional): 14-day interventional period, where subjects will perform dialysis exchanges using the IDA according to the below visit schedule.
Third period (Follow up): 14-day follow up period, during which the study staff will call the subject once weekly to inquire about device-related SAEs and any changes to concomitant medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The subjects will undergo a single peritoneal dialysis exchange procedure at the PD clinic, under the supervision of the medical staff and instructed about its operation. Further exchanges will be performed by the subjects themselves at home. The study includes two cohorts and two phases: in the first phase (phase I), 20 subjects will be recruited as Cohort 1 to undergo a single exchange in the medical center using the IDA. Following the completion of recruitment of all 20 subjects and the performance of the single on site exchange, the Sponsor will perform an interim analysis of the results for safety and initial feasibility, followed by submission of the results to the MoH and approval of the second phase (phase II). Subjects will be treated with their routine dialysis device for 14 days, followed by a treatment with the IDA for a period of 30 days, and then an additional period of 14 days of treatment with their routine dialysis device.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Intelligent Dialysis Assistant (IDA)Each subjects will be treated with his prescribed dialysis device for 14 days, followed by a treatment period of 30 days with the investigational IDA system, and concluding with additional 14 days of treatment with the prescribed dialysis device. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with CKD stage 5 treated by continuous ambulatory peritoneal dialysis (CAPD)
- Male or female, Age >18 years
- Mental ability to understand study procedures and provide an informed consent
- More than 3 months on PD (Peritoneal Dialysis)
- At least 3 daily exchanges
Key exclusion criteria (9 listed)
- Need of cycler (APD, Automated Peritoneal Dialysis)
- Known mechanical problem (drainage, fill) during the last month prior to enrollment
- Pregnant or breastfeeding women
- subject who is unwilling or unable to comply with study procedures
- Known Peritonitis or other catheter associated infections during the last 3 months prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intelligent Dialysis Assistant (IDA)The IDA is intended for home dialysis for subjects who are stage 5 kidney diease patients and who perform Peritoneal Dialysis. The system is used deveral times a day for approximately 20 minutes for each cycle. During the interventional period, subjects will use only the investigational IDA system for their in/out exchanges. | Device | Treatment |
Primary outcome
Device-Related Serious Adverse Event Incidence
Time frame: 14 days
Incidence of device-related SAEs throughout the active investigational phase (14 days).
AE during on site exchange
Time frame: 1 day
Incidence of device-related adverse events during the on-site exchange - phase I of the study.
4 secondary outcomes
Procedure Time Length
Time frame: 14 days
Usability Questionnaire
Time frame: 14 days
Device-Related Serious Adverse Events Incidence During Follow Up Period
Time frame: 14 days
Renal Treatment Internal Questionnaire
Time frame: 42 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Disease Stage 5
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatiana Tansyochuk, MD principal investigator
Carmel MC, Haifa
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent Dialysis Assistant (IDA) in people with Chronic Kidney Disease Stage 5, run by liberDi Ltd. at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maya Shick, b.sc (972523313350, Hila@liberdi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device-Related Serious Adverse Event Incidence (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022; AzTrials last refreshed its copy on 31 Oct 2026.