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 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT01111266
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent obtained from patient or parents/ guardian.
* Subject age \>= 18
* Effective blood flow 350 ml/min and dialysate flow of 500 ml/min
* On hemodialysis for a minimum of 3 months
* Use of Cimino- or Gore-tex shunts
* Routine dialysis-treatment for 240 min
* Documented dialysis adequacy parameter that has been stable for past 3 months
* Plan to dialyze at participating hemodialysis centre for at least 3-months duration.
* Free from any currently known unusual clotting or access problems
* Hepatitis B surface antigen (HbsAg) negative, documented within the past 90 days or Hepatitis B surface antibody (anti-HBs) positive.
* Anti Hepatitis C Virus (Anti-HCV) negative, documented within the past 90 days
* Anti Human Immunodeficiency Virus (Anti HIV) negative, documented within the past 90 days
* Hematocrit (HCT) between 25 and 40% or haemoglobin (Hb) not less than 8 g/dL, as documented 14 days prior to the first treatment
Exclusion Criteria:
* Patients who are unable to tolerate an effective blood flow of 350 ml/min
* Patients using catheter for dialysis
* Pregnant or nursing woman. Women of childbearing potential must agree to avoid pregnancy during the study period by use of hormonal contraception (implantable; patch; oral) and/ or double-barrier methods (any double combination of: IUD; condom with spermicidal gel; diaphragm; sponge; cervical cap)
* Previous plan for extended absences from the participating hemodialysis centre
* Expected to be transplanted (living related donor) within the maximum of 3 months for the study period
* Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01111266
Study Brief:
Protocol Section:
NCT01111266