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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT04523220
Eligibility Criteria:
Inclusion Criteria:
* Participants must be at least 18 years of age
* Patients with end-stage renal disease on hemodialysis (including hemodiafiltration) for ≥3 months, receiving dialysis at least 9 hours a week and stable in the view of the investigator
* Body weight of at least 50 kg
* Male and/or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria:
* Recent (\<6 months before screening) clinically significant bleeding
* Hemoglobin (Hb) \< 9.0 g/dL at screening
* Platelet count \< 100 x 10\^9/L
* aPTT or PT \> ULN (upper limit of normal)
* Hepatic disease associated with ALT \> 3x ULN, or total bilirubin \>2x ULN with direct bilirubin \> 20% of the total
* Sustained uncontrolled hypertension (diastolic blood pressure ≥100 mmHg and/or systolic blood pressure ≥ 180 mmHg)
* Known intracranial neoplasm, arteriovenous malformation or aneurysm
* Known bleeding disorders e.g. von-Willebrand disease or Hemophilia A, B or C
* Recent (\<3 months before screening) thromboembolic event, e.g. acute coronary syndrome, stroke or VTE (except dialysis access thrombosis)
* Recent (\<3 months before screening) major surgery or scheduled major surgery during study participation
* Scheduled living donor renal transplant during study participation
* Persistent heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher
* Receiving antiplatelet therapy except daily ASA ≤ 150 mg/day
* Receiving anticoagulation in therapeutic doses, other than standard anticoagulation during the hemodialysis procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04523220
Study Brief:
Protocol Section:
NCT04523220