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 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT02675569
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients age ≥ 55; (AUS sites : adult patients age ≥ 65);
2. a). Started hemodialysis using a tunnelled, or non-tunnelled catheter for vascular access AND ≤ 1 previously unsuccessful fistula attempt; OR b).Changing over from peritoneal dialysis AND no functioning arteriovenous fistula available at HD start;
3. Treated with hemodialysis for 365 days or less at the time of consent (374 days or less at the time of randomization);
4. Clinically and cognitively stable (able to provide consent within 365 days of hemodialysis start);
5. Hemodialysis is the intended modality of treatment;
6. End-stage (permanent) kidney failure unlikely to recover kidney function according to the attending nephrologist;
7. Eligible for a fistula attempt as determined by the local multidisciplinary access team;
8. Planning to remain in the current dialysis center/service for at least 6 months;
Exclusion Criteria:
1. Started hemodialysis with a fistula or have a patent fistula already in place or had \>1 unsuccessful attempt; (AUS sites: or previously functioning fistula no longer working);
2. . Has had a prior arteriovenous graft creation;
3. Imminent transplant planned (within 6 months);
4. Metastatic malignancy or other condition associated with a life expectancy of less than 6 months, in the opinion of the attending nephrologist;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT02675569
Study Brief:
Protocol Section:
NCT02675569