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

Primary Purpose

Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
xevonta
Sponsored by
B.Braun Avitum AG
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Disease focused on measuring in vivo KUF, ß2M, leptin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georg-Haas Dialysezentrum der PHV

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 15, 2010
Last Updated
March 13, 2012
Sponsor
B.Braun Avitum AG
Collaborators
Labor Limbach, Heidelberg, Germany, Clin-Sol, Würzburg, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01111266
Brief Title
Determination of in Vivo Ultrafiltration Coefficient (KUF) in Patients With Chronic Kidney Disease (CKD)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
B.Braun Avitum AG
Collaborators
Labor Limbach, Heidelberg, Germany, Clin-Sol, Würzburg, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease
Keywords
in vivo KUF, ß2M, leptin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
xevonta
Intervention Description
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.
Primary Outcome Measure Information:
Title
in vivo KUF
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Determination of removal rates
Description
Removal rates for urea, phosphate, creatinine, albumin, leptin and Beta2-microglobulin will be determined.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen Wagner, Prof. Dr.
Organizational Affiliation
B.Braun Avitum AG
Official's Role
Study Director
Facility Information:
Facility Name
Georg-Haas Dialysezentrum der PHV
City
Gießen
State/Province
Hessen
ZIP/Postal Code
35392
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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