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 @ 2:13 PM
Ignite Modification Date:
2025-12-24 @ 2:13 PM
NCT ID:
NCT05769595
Eligibility Criteria:
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Japanese descent with all 2 biological parents of Japanese descent
* On hemodialysis (HD) or hemodiafiltration (HDF) with single-pool Kt/V (spKt/V) ≥1.2, using arteriovenous (AV) fistula or AV graft ≥3 months prior to Screening 1 at a healthcare center, and is on the same dialysis regimen ≥2 weeks prior to Screening 1
* Be judged to plan to continue or anticipate the use of the current AV fistula or AV graft until the poststudy visit
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* On peritoneal dialysis or other dialysis modalities except for HD and HDF
* History of deep vein thrombosis or pulmonary embolism
* History of vascular access thrombosis within 1 month prior to Screening 1
* Personal or family history of bleeding disorder
* History of GI bleeding, duodenal polyps or active gastroduodenal ulcer within 5 years prior to Screening 1, or history of severe hemorrhoidal bleed within 3 months prior to Screening 1
* History of frequent epistaxis within 3 months prior to Screening 1 or active gingivitis
* At the time of screening or predose, planned significant dental procedures, or other planned surgical procedures within duration of participation in the trial
* History of receiving any human immunoglobulin preparation such as intravenous immunoglobulin (IVIG) or a brand of Rho(D) immune globulin (RhoGAM) within 1 year prior to Screening 1
* History of receiving any biological therapy within 3 months prior to Screening 1, or vaccination within 1 month prior to the dose of study intervention
* Requires or anticipates requiring the use of following prohibited medications until the poststudy visit: anticoagulants, antiplatelet medications and non-steroidal anti-inflammatory drugs (NSAIDs)
* Participated in another investigational study within 1 month prior to Screening 1
* Has blood coagulation test (activated partial thromboplastin time \[aPTT\] or prothrombin time \[PT\]) above 1.2X upper limit of normal (ULN) at Screening 1 from the central laboratory for safety
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT05769595
Study Brief:
Protocol Section:
NCT05769595