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 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT05342935
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects with CKD stage 5 under peritoneal dialysis
* Age ≥18 years
* Mental ability to understand the study procedures and provide informed consent
* At least 3 months on peritoneal dialysis prior to enrollment
* At least 3 daily exchanges
* Stable PD prescription for the last 2 months
* Subject who is self-treated
Exclusion Criteria:
* Need of cycler (APD)
* Known Mechanical problem during the last month (i.e. drainage or fill problems)
* Pregnant or breastfeeding women, and women with childbearing potential who is unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the entire clinical trial period.
* Subjects who are unwilling or unable to comply with study procedures
* Known Peritonitis or other catheter related infection during the last 3 months prior to enrollment
* Known Congestive Heart Failure stage III-IV
* Any history of kidney malignancy
* Any planned hospitalization for elective Procedure(s)throughout the duration of participation in the study
* Non-elective hospitalization in the last 3 months prior to enrollment
* Any other medical or mental condition, that at the investigator's discretion may prevent the subject from participating in the study
* Participation in any other clinical study within 4 weeks prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT05342935
Study Brief:
Protocol Section:
NCT05342935