Carry Life@ UF System Clinical Study

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The Carry Life UF system performs peritoneal ultrafiltration by adding glucose to the low glucose strength (1.36%) peritoneal dialysis fluid which has been instilled into the peritoneal cavity prior to the connection of the device. By maintaining a stable glucose concentration in the intraperitoneal fluid during the 5-hour treatment, the ultrafiltration can be increased compared to a standard CAPD dwell.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Triomed AB
• Collaborator: Iqvia Pty Ltd

Criteria

Inclusion Criteria:

1. Age ≥ 18 years.

2. Subjects with ESKD treated with PD for at least three (3) months.

3. A PD prescription of 2-4 CAPD dwells/day unchanged for a minimum of two (2) weeks, with at least one 1.5-2L, 2.27% glucose day dwell daily.

4. Subjects must be able to tolerate a 2 L PD fill volume for the PET.

5. Subjects using the Baxter PD system with a MiniCap transfer set.

6. In the opinion of the Investigator, the subject has the capacity to learn how to use the Carry Life® UF system or has a caregiver who can do so.

7. Obtained written consent to participate in the study.

Exclusion Criteria:

1. A PD prescription including a regular 3.86% glucose day dwell.

2. An episode of peritonitis within the last three (3) months.

3. Serum potassium > 6 mmol/l within the last three (3) months.

4. Serum urea > 35 mmol/l within the last three (3) months.

5. Clinical signs of dehydration.

6. Systolic blood pressure < 100 mmHg within the last month.

7. Known diagnosis of clinically significant aortic stenosis.

8. Clinical condition of unstable diabetes.

9. Subjects with a life expectancy of < six (6) months.

10. Evidence of any other diseases or medical conditions that may interfere with the planned treatment or affect participant compliance.

11. Participation in clinical trials, interfering with the present study, within the previous month.

12. Anticipated living donor kidney transplantation within six (6) months of screening.

13. Pregnant, breastfeeding, or women of childbearing potential who are not using an effective method of contraception (hormonal contraceptives or barrier contraceptive methods).