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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT01001351
Eligibility Criteria:
Inclusion Criteria:
1. Age of at least 18 years.
2. Chronic kidney disease with anticipated start of hemodialysis within 3 months or current hemodialysis dependence.
3. Planned creation of a new upper extremity AVG or "jump" graft
Exclusion Criteria:
1. Patients for whom this is the only potential site for an upper extremity vascular access.
2. Creation of a new AVG or "jump" graft in an upper extremity previously treated with an investigational gene or cell based therapy, or locally with an investigational pharmacological agent.
3. On physical examination or by other means, suspected proximal vein stenosis, occlusion, lack of continuity with the subclavian vein, central venous stenosis or central venous occlusion.
4. History or presence of an arterial aneurysm.
5. Previous treatment with PRT-201.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01001351
Study Brief:
Protocol Section:
NCT01001351