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 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT06314503
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years of age
* Treated with PD for at least 3 months prior to enrolment
* Well-functioning peritoneal catheter and no peritoneal catheter replacement for at least a month prior to enrolment
* No PD-related infection (exit-site infection, tunnel infection or peritonitis) less than 8 weeks prior to enrolment (counting from the day that the treatment has been finished).
* Previous or current use of Extraneal® with no contra-indications
* Capable of understanding the patient information sheet and informed consent form (ICF) and give informed consent
* Willing and able to comply with all study procedures and attend all study visits
Exclusion Criteria:
* Patients who are unable to provide informed consent
* Patients who are unable to comply with study procedures
* Patients who received renal replacement therapy other than conventional PD less than 8 weeks prior to enrolment
* Patients who participated in an intervention trial less than 8 weeks prior to enrolment or are currently participating in an intervention trial. Patients in an observational study without any interventions or in post-market surveillance do not need to be excluded.
* Patients with a PD-related infection (exit-site infection, tunnel infection or peritonitis) less than 8 weeks prior to enrolment (counting from the day that the treatment has been finished)
* Patients with peritoneal catheter dysfunction or mechanical issues less than one month prior to enrolment
* Patients who have never used Extraneal® dialysis fluid or have a contra-indication for Extraneal®: a known allergy to cornstarch or icodextrin; maltose or isomaltose intolerance; glycogen storage disease
* Patients with an incompatible PD connection to the device (e.g. Fresenius PD system)
* Patients with haemoglobin concentrations \< 6.2 mmol/L (\< 10 g/dL) less than 8 weeks prior to enrolment
* Patients with hyperkalemia (\> 6.0 mmol/L) or hyponatremia (\< 130 mmol/L) in the 8 weeks prior to enrolment
* Patients with hypocalcemia (plasma total calcium concentration corrected for albumin \<2.20 mmol/L or ionized calcium \<1.15 mmol/L) or hypomagnesemia (plasma magnesium concentration \<0.70 mmol/L) in the 8 weeks prior to enrolment
* Patients with any serious medical condition which in the opinion of the investigator, may adversely affect the safety of the participant and/or effectiveness of the study
* Female patients who are either (planning to become) pregnant within the study period or breast feeding
* Patients with a life expectancy \<3 months
* Anticipated living donor kidney transplantation \<3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06314503
Study Brief:
Protocol Section:
NCT06314503