Clinical trial NCT05342935: A Prospective, Open-label, Multi-center Pilot Study to Evaluate the Safety, Feasibility and Usability of the IDA
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease Stage V
Lead sponsor: liberDi Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Safety Endpoint - Serious Adverse Events Rate
timeFrame: 42 days
Secondary outcomes:
measure: IDA Usability by Investigator
timeFrame: 14 days
measure: IDA Usability by Subject
timeFrame: 14 days
measure: IDA Feasibility
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Imperial College Medical Center
name: Richard Corbett, MD
role: PRINCIPAL_INVESTIGATOR
References: