Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04808011 |
Other study ID # |
CSP-028-20 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 22, 2021 |
Est. completion date |
December 30, 2023 |
Study information
Verified date |
November 2022 |
Source |
liberDi Ltd. |
Contact |
Maya Shick, b.sc |
Phone |
972523313350 |
Email |
Hila[@]liberdi.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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.