A Prospective, Open-label, Multi-center Pilot Study to Evaluate the Safety, Feasibility and Usability of the IDA

Chronic Kidney Disease Stage V Clinical Trial

— CSP-027-21  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05342935
• Other study ID #: liberDi
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: March 2023

Study information

• Verified date: April 2022
• Source: liberDi Ltd.
• Contact: Maya Shick
• Phone: 97248228090
• Email: maya[@]liberdi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage V
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
liberDi Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	42 days
Secondary	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	14 days
Secondary	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.	14 days
Secondary	IDA Feasibility	The feasibility of the treatment will be evaluated by recording time length of the in/out PD exchange procedure	14 days