A Single Arm, Multi-Center Study To Evaluate The Intelligent Dialysis Assistant (IDA)

NCT ID: NCT04808011

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-22
• Study Completion Date: 2023-12-30

Brief 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. 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:

1. 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.

2. Second period (Interventional): 14-day interventional period, where subjects will perform dialysis exchanges using the IDA according to the below visit schedule.

3. 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.

Conditions

Chronic Kidney Disease Stage 5

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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.

Group Type: EXPERIMENTAL

Intelligent Dialysis Assistant (IDA)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

liberDi Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tatiana Tansyochuk, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel MC, Haifa

Locations

Soroka Medical Center

Beersheba, , Israel

Site Status: RECRUITING

Carmel MC

Haifa, , Israel

Site Status: RECRUITING

Meir Medical Center

Kfar Saba, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Maya Shick, b.sc

Role: CONTACT

Hila@liberdi.com

972523313350

Facility Contacts

Marina Vorobiov, MD

Role: primary

marinavo@clalit.org.il

08-6400373

Moran Zaken, Mrs.

Role: primary

Yael Einbinder, MD

Role: primary

Other Identifiers

CSP-028-20

Identifier Type: -

Identifier Source: org_study_id