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 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT06024135
Eligibility Criteria:
Inclusion Criteria:
1. Male or female aged 18 years or over;
2. Treated with short-daily hemodialysis (1.5-3 h sessions) 5-6 times a week for at least 3 months;
3. Estimated Urea removal concentration between \[220 to 550\] mmol. (Estimation based on the formula: (\[Dry Weigh in kg\]\*\] x 0,6)\*(\[) x (\[Last pre-dialysis urea concentration in mmol/L\]\*\] x 0,5).
4. Well-functioning vascular access (native fistula or graft or permanent veinous catheter) defined as:
* Capable of providing a blood flow rate of ≥200 mL/min, AND
* Absence of vascular access revision for at least 3 months
5. For females of reproducible age, negative urinary pregnancy test and use of appropriate birth control method(s);
6. Ability to understand the informed consent and give informed consent;
7. Willingness and ability to comply with study procedures and to attend all study follow up visits
Exclusion Criteria:
1. Post-dialysis body weight below 41.0 kg
2. Hb \<10.0 g/L, or pre-dialysis \[Na\] \< 132 and \> 145 mmol/L, pre-dialysis \[K\] \< 3.5 and \> 6 mmol/L and pre-dialysis \[HCO3\] \< 15 and \> 30 mmol/L in the latest determination, within the 6 weeks prior to enrollment.
3. One or more pre-dialysis urea concentration \<10 mmol/L or \>30mmol/L within the 6 weeks prior to enrollment.
4. Subjects requiring UF volume \>2.0L per 2hr treatment in any dialysis session within 6 weeks prior to enrollment.
5. Any documented episode of hemolysis within the 6 months prior to enrolment.
6. Any infection related to the vascular access within the 4 weeks prior to enrolment.
7. History of impaired liver function (normal Factor V).
8. Severe uncontrolled arterial hypertension (systolic BP\>180mmHg or diastolic BP \>104 mmHg).
9. Known chronic obstructive pulmonary disease.
10. Anticipation of a living donor kidney transplantation within the 2 months of the study period.
11. Pregnant, breast feeding, or planning a pregnancy during the study period.
13\. Any known psychosocial problems which may negatively influence dialysis treatment.
14\. History of drug and/or alcohol abuse within the last 3 months prior to enrolment.
15\. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06024135
Study Brief:
Protocol Section:
NCT06024135