Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT05874804
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05874804
Study Brief:
Protocol Section:
NCT05874804