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

March 13, 2012 updated by: B.Braun Avitum AG

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Gießen, Hessen, Germany, 35392
        • Georg-Haas Dialysezentrum der PHV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in vivo KUF
Time Frame: 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.
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B.Braun Avitum AG

Collaborators

Labor Limbach, Heidelberg, Germany
Clin-Sol, Würzburg, Germany

Investigators

  • Study Director: Jürgen Wagner, Prof. Dr., B.Braun Avitum AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

April 15, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (Estimate)

April 27, 2010

Study Record Updates

Last Update Posted (Estimate)

March 14, 2012

Last Update Submitted That Met QC Criteria

March 13, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA-I-H-09-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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