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
Clareo Health | Determination of in Vivo Ultrafiltration Coefficient (KUF) in Patients With Chronic Kidney Disease (CKD)
