Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
B.Braun Avitum AG
With
Labor Limbach, Heidelberg, Germany
Clin-Sol, Würzburg, Germany
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
