Chronic Kidney Disease Stage VCSP-027-21NCT05342935
A Prospective, Open-label, Multi-center Pilot Study to Evaluate the Safety, Feasibility and Usability of the IDA
A study testing Inteligent Dialysis Assistant (IDA) in people with Chronic Kidney Disease Stage V, run by liberDi Ltd..
Trial summary
This is a multi-center, open label, cross-over clinical study. A total of 15 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 120 years
- Conditions the study is for
- Chronic Kidney Disease Stage V
- What is being tested?
- Inteligent Dialysis Assistant (IDA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Mar 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects with CKD stage 5 under peritoneal dialysis
- Age ≥18 years
- Mental ability to understand the study procedures and provide informed consent
- At least 3 months on peritoneal dialysis prior to enrollment
- At least 3 daily exchanges
- Stable PD prescription for the last 2 months
- Subject who is self-treated
Who cannot join
- Need of cycler (APD)
- Known Mechanical problem during the last month (i.e. drainage or fill problems)
- Pregnant or breastfeeding women, and women with childbearing potential who is unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the entire clinical trial period.
- Subjects who are unwilling or unable to comply with study procedures
- Known Peritonitis or other catheter related infection during the last 3 months prior to enrollment
- Known Congestive Heart Failure stage III-IV
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- Any history of kidney malignancy
- Any planned hospitalization for elective Procedure(s)throughout the duration of participation in the study
- Non-elective hospitalization in 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
No sites are listed yet.
About this study
Official title: A Prospective, Open-label, Cross-over, Multi-center Pilot Study to Evaluate the Safety, Feasibility and Usability of the IDA in Subjects Suffering From a Stage 5 Kidney Disease and Who Are Treated With Peritoneal Dialysis
This is a multi-center, open label, cross-over clinical study. A total of 15 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:
Read more
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 V
- Being tested
- Inteligent Dialysis Assistant (IDA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inteligent Dialysis Assistant (IDA)Device
The IDA is a small dialysis system that allows a higher level of freedom to the patients, permitting them to perform the PD exchange while continuing to do their everyday activities
| Study group | Role | What they receive |
|---|---|---|
| IDA treatment | Experimental | Each subject will be treated with his prescribed manual PD for 14 days, followed by a treatment period of 14 days with the investigational IDA system, and concluding with additional 14 days of treatment with the manual PD. Receives: Device: Inteligent Dialysis Assistant (IDA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint - Serious Adverse Events Rate
The safety of the IDA, as determined by the accumulative incidence of device-related SAEs throughout the 14-day prospective study period
Measured: 42 days
Secondary outcomes (3)
IDA Usability by Investigator
The usability of the IDA will be evaluated by completing an internal usability questionnaire by the investigator that will check the operation of the various system controls and the ease of use
Measured: 14 days
IDA Usability by Subject
The completion of the internal Satisfaction and QoL internal questionnaire by each participating subject. Answers in the questionnaire range from 1 (poor) to 5 (excellent), and the results range from 6-30 - the higher the result, the higher the subject's wellbeing.
Measured: 14 days
IDA Feasibility
The feasibility of the treatment will be evaluated by recording time length of the in/out PD exchange procedure
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study startJun 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMar 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 VStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will pursue their usual manual PD exchanges, followed by the treatment with the investigational device and then back to their manual PD.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- liberDi Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Corbett, MD, Principal investigator, Imperial College Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342935
- Sponsor's protocol ID
- liberDi
- Acronym
- CSP-027-21
- Status last verified
- Apr 2022
- First submitted
- 18 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Cross-over, Multi-center Pilot Study to Evaluate the Safety, Feasibility and Usability of the IDA in Subjects Suffering From a Stage 5 Kidney Disease and Who Are Treated With Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT05342935
- Acronym / sponsor ID
- CSP-027-21 / liberDi
- Conditions
- Chronic Kidney Disease Stage V
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- liberDi Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 25 Apr 2022 (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 15 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will pursue their usual manual PD exchanges, followed by the treatment with the investigational device and then back to their manual PD.
| Arm | Type | Receives |
|---|---|---|
| IDA treatment | Experimental | Device: Inteligent Dialysis Assistant (IDA)Each subject will be treated with his prescribed manual PD for 14 days, followed by a treatment period of 14 days with the investigational IDA system, and concluding with additional 14 days of treatment with the manual PD. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subjects with CKD stage 5 under peritoneal dialysis
- Age ≥18 years
- Mental ability to understand the study procedures and provide informed consent
- At least 3 months on peritoneal dialysis prior to enrollment
- At least 3 daily exchanges
Key exclusion criteria (11 listed)
- Need of cycler (APD)
- Known Mechanical problem during the last month (i.e. drainage or fill problems)
- Pregnant or breastfeeding women, and women with childbearing potential who is unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the entire clinical trial period.
- Subjects who are unwilling or unable to comply with study procedures
- Known Peritonitis or other catheter related infection 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 |
|---|---|---|
| Inteligent Dialysis Assistant (IDA)The IDA is a small dialysis system that allows a higher level of freedom to the patients, permitting them to perform the PD exchange while continuing to do their everyday activities | Device | IDA treatment |
Primary outcome
Safety Endpoint - Serious Adverse Events Rate
Time frame: 42 days
The safety of the IDA, as determined by the accumulative incidence of device-related SAEs throughout the 14-day prospective study period
3 secondary outcomes
IDA Usability by Investigator
Time frame: 14 days
IDA Usability by Subject
Time frame: 14 days
IDA Feasibility
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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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.
Richard Corbett, MD principal investigator
Imperial College Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Inteligent Dialysis Assistant (IDA) in people with Chronic Kidney Disease Stage V, run by liberDi Ltd..
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 11 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 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 (97248228090, maya@liberdi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint - Serious Adverse Events Rate (time frame: 42 days). 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 25 Apr 2022.