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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT06671535
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of CKD stage 5D, maintenance hemodialysis not less than 3 months prior screening;
* Moderate-to-severe pruritis (WI-NRS score ≥ 4);
* Adequate dialysis dose (spKt/V≥1,4 and/or eKt/V≥1,2);
* Dialysis treatment regimen: three sessions per week of at least 4 hours duration;
* Signed informed consent.
Exclusion Criteria:
* Presence of active skin disease, cholestasis, severe secondary hyperparathyroidism and other conditions that, in the investigator's opinion, may be responsible for pruritus.
* Noncompliance of the patient with the protocol (in the investigator's opinion).
* Use of haemodiafiltration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06671535
Study Brief:
Protocol Section:
NCT06671535