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

Study Overview
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Brief Summary
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The purpose of this study is to determine the in-vivo ultrafiltration coefficient for different sizes of xevonta High-Flux dialyzers following FDA guidelines.

Official Title
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Evaluation of Performance and Safety Profile of Xevonta High Flux Dialyzer With Special Focus on Determination of in Vivo Ultrafiltration Coefficient in Patients With CKD

Conditions
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Kidney Disease

Intervention / Treatment
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* Device: xevonta


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: xevonta|Patients will be treated with 3 different sizes of xevonta (2 weeks each size) for determination of in vivo KUF following FDA Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers. In addition blood samples will be collected for determination of removal rates of different small molecules and protein.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in vivo KUF | The objective of this study is to to determine in vivo KUF for three different sizes (1.2; 1.8 and 2.3 m^2) of xevonta High-Flux to compare obtained data with respective in vitro KUF data. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of removal rates | Removal rates for urea, phosphate, creatinine, albumin, leptin and Beta2-microglobulin will be determined. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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in vivo KUF, ß2M, leptin