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

Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111266
• Other study ID #: BA-I-H-09-02
• Status: Completed
• Phase: N/A
• First received: April 15, 2010
• Last updated: March 13, 2012
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: B.Braun Avitum AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Kidney Disease
• Kidney Diseases

Intervention

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.

Locations

Country	Name	City	State
Germany	Georg-Haas Dialysezentrum der PHV	Gießen	Hessen

Sponsors (3)

Lead Sponsor	Collaborator
B.Braun Avitum AG	Clin-Sol, Würzburg, Germany, Labor Limbach, Heidelberg, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Determination of removal rates	Removal rates for urea, phosphate, creatinine, albumin, leptin and Beta2-microglobulin will be determined.	6 weeks	No