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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT04247867
Eligibility Criteria:
Inclusion Criteria:
* patient on chronic hemodialysis or hemodiafiltration for at least 12 weeks,
* age 18 years old or more,
* a functioning arteriovenous fistula or graft as a permanent dialysis vascular access,
* being able to give an informed consent to participate in the survey;
Exclusion Criteria:
* planned kidney transplantation, transition to peritoneal dialysis or to another dialysis center within 12 weeks of the start of the study,
* active chronic inflammation (e.g., an active autoimmune disease or an open wound), chronic ongoing infection or cancer in last 4 weeks,
* acute febrile illness in last 4 weeks,
* new cardiovascular or neurovascular event in last 4 weeks,
* a need for hospitalization in the last 4 weeks,
* clinically evident malnutrition and/or body mass index of 19 kg/m2 and/or loss of body weight for 5% in last 3 months,
* immunosuppressive treatment,
* expected survival of less than 1 year,
* pregnancy or breast-feeding,
* indication for dietary supplements to increase calorie and / or protein intake,
* specific indication for carrying out hemodiafiltration instead of hemodialysis as per attending physician,
* serum albumin concentration \<32 g/l at screening to enter the study,
* inability to follow the study diet or test procedures,
* rapid reduction of residual renal function in the period prior to entry into the study,
* intolerant of on-line haemodiafiltration (infusion intolerance);
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04247867
Study Brief:
Protocol Section:
NCT04247867