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:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT04445558
Eligibility Criteria:
Inclusion Criteria:
* Patient with renal failure, on hemodialysis for at least 12 months;
* Hemodialysis patient in 3 weekly sessions on a device with a standard permeability membrane (polysulfone, polyethersulfone or polyartylethersulfone type);
* Malnourished patient, on intradialytic parenteral nutrition for at least 6 months;
* Patient who may benefit, according to the doctor, from a change in dialysis and nutrition strategy:
* Patient who signed an informed consent form to participate in the study
Exclusion Criteria:
* Known allergy to PEPA® ;
* Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
* Patient with a chronic infection in progress;
* Patient with life expectancy \<6 months according to the investigator;
* Inability to understand information related to the study (linguistic, psychological, cognitive reason, etc.);
* Pregnant woman or likely to be (of childbearing age, without effective contraception) or breastfeeding;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient not benefiting from a social security scheme.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04445558
Study Brief:
Protocol Section:
NCT04445558