Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04808011
Study type Interventional
Source liberDi Ltd.
Contact Maya Shick, b.sc
Phone 972523313350
Email Hila@liberdi.com
Status Recruiting
Phase N/A
Start date December 22, 2021
Completion date December 30, 2023

See also
  Status Clinical Trial Phase
Terminated NCT03539861 - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients N/A
Recruiting NCT03311321 - Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients N/A
Completed NCT05630729 - Living With CKD: An E-Learning Platform for Adolescents With CKD About the Disease and Its Management N/A
Withdrawn NCT03998917 - Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis.
Recruiting NCT05489120 - Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD) N/A
Completed NCT04207203 - Healthy Diet Rich in Potassium to Chronic Kidney Disease With Sodium Zirconium Cyclosilicate: A Feasibility Study N/A
Recruiting NCT01591876 - Exercise and Vascular Function in Haemodialysis Patients Phase 2
Not yet recruiting NCT04608422 - Bioeletric Stimulation in Patients With Chronic Kidney Failure N/A
Completed NCT03868371 - Acute Changes in the Mineral Metabolism After a High Phosphorous Containing Meal in Dialysis Patients N/A
Active, not recruiting NCT05225454 - The Life Style Patterns and the Development Trend of Chronic Diseases in Healthy and Sub-healthy Groups Were Analyzed by Using Data-mining Techniques
Completed NCT03459807 - Blood Pressure Lowering in Dialysis (BOLD) Trial Phase 2
Not yet recruiting NCT03005847 - The Effect of Fermented Papaya Preparation on Patients With Chronic Kidney Disease Under Dialysis Receiving Intravenous Iron N/A
Recruiting NCT05726526 - CKD Specific Telemonitoring Platform to Minimize Adverse Outcomes in High Risk CKD Patients N/A
Recruiting NCT04330807 - Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease N/A
Active, not recruiting NCT02858778 - Timing of Acute Palliative Care Consultation in Critically Ill Patients N/A
Active, not recruiting NCT04034966 - Utility of Telemedicine in the Follow-Up of Patients in Peritoneal Dialysis N/A
Completed NCT04012957 - Desidustat in the Treatment of Anemia in CKD Phase 3
Terminated NCT02039167 - Left Atrial Appendage Occlusion vs. Usual Care in Patients With Atrial Fibrillation and Severe Chronic Kidney Disease N/A
Completed NCT01764854 - Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis Phase 2
Active, not recruiting NCT06037265 - PR-0164 First in Human Clinical Trial of the PAVmed PortIO Intraosseous Infusion System N/A