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 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT02222402
Eligibility Criteria:
Inclusion Criteria:
1. Prevalent Stage 5 CKD patients (GFR \<15 mL/min) receiving maintenance haemodialysis therapy for more than 3 months
2. Male or female
3. Aged \>18 years
4. Able to provide written informed consent
Exclusion Criteria:
1. Patients unlikely to be on HD for \> 6 months - (this includes cachectic patients, those with severe heart failure, patients in whom dialysis withdrawal is being considered, and patients likely to receive a live-donor transplant or transfer to PD in that period of time);
2. Less than 3 months after the initiation of haemodialysis (patients in this time-frame are generally less clinically stable, many having vascular access procedures performed, and rates of inter-current events, including death and hospitalisation, are very much higher in the first 3 months after commencement of chronic haemodialysis);
3. Deemed to be clinically unstable by treating physician;
4. Dementia or severe cognitive impairment (as will be unable to give consent and/or complete questionnaire assessments);
5. Severe psychiatric disorders - except treated stable
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT02222402
Study Brief:
Protocol Section:
NCT02222402