Carry Life@ UF System Clinical Study

Launched by TRIOMED AB · May 15, 2023

Keywords

ClinConnect Summary

A study of the peritoneal ultrafiltration achieved with Carry Life® UF system compared to standard peritoneal dialysis (PD) therapy, in CAPD patients.

The study consists of the following five (5) phases:

1. Inclusion phase.
2. In-clinic treatment phase for dose determination and safety evaluation.
3. Randomization phase.
4. Transition to home treatment phase.
5. Home treatment phase for efficacy and safety evaluation.

The in-clinic phase consists of one 2.27% Peritoneal equilibrium test (PET) and two Carry Life® UF treatments; one with a 11 g/h glucose dose and one with a 15 g/h glucose ...

Gender

ALL

Eligibility 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).