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

Not Applicable

Completed

• Conditions: Kidney Disease

• Registration Number: NCT01111266
• Lead Sponsor: B.Braun Avitum AG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-27
• Primary Completion: 2011-08
• Status Verified: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-13
• Last Update Posted: 2012-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
in vivo KUF	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Determination of removal rates	6 weeks	Removal rates for urea, phosphate, creatinine, albumin, leptin and Beta2-microglobulin will be determined.

Trial Locations

Locations (1)

Georg-Haas Dialysezentrum der PHV; 🇩🇪 Gießen, Hessen, Germany