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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT04360694
Eligibility Criteria:
Inclusion Criteria:
* Adults aged \> 18 years
* Start of maintenance hemodialysis treatment due to advanced CKD stage 5D
* Patients who are about to start HD or have already started HD within a period of ≤ 2 weeks
* Glomerular filtration rate \<= 10 mL/min/1.73 m2, as estimated by means of CKD-EPI formula.
Exclusion Criteria:
* Age \< 18 years
* Acute kidney injury or acute on chronic kidney injury
* eGFR higher than 10 mL/min/1.73 m2
* UO \< 600 mL/day
* Already treated with other replacement therapies (peritoneal dialysis or kidney transplant)
* Unable or unwilling to give informed consent.
* Unable to comply with trial procedures, e.g., collection of UO.
* Likely survival prognosis or planned modality or centre transfer \< 6 months.
* Patients who are in the waiting list for a living kidney transplant
* Associated diseases: active neoplastic disease; refractory congestive heart failure (type IV NYHA, ejection fraction ≤ 30%) requiring high ultrafiltration volumes per session.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04360694
Study Brief:
Protocol Section:
NCT04360694