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

This study has been completed.
Sponsor:
Collaborators:
Labor Limbach, Heidelberg, Germany
Clin-Sol, Würzburg, Germany
Information provided by (Responsible Party):
B.Braun Avitum AG
ClinicalTrials.gov Identifier:
NCT01111266
First received: April 15, 2010
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention
Kidney Disease
Device: xevonta

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

Resource links provided by NLM:


Further study details as provided by B.Braun Avitum AG:

Primary Outcome Measures:
  • in vivo KUF [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Removal rates for urea, phosphate, creatinine, albumin, leptin and Beta2-microglobulin will be determined.


Enrollment: 12
Study Start Date: March 2010
Study Completion Date: March 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111266

Locations
Germany
Georg-Haas Dialysezentrum der PHV
Gießen, Hessen, Germany, 35392
Sponsors and Collaborators
B.Braun Avitum AG
Labor Limbach, Heidelberg, Germany
Clin-Sol, Würzburg, Germany
Investigators
Study Director: Jürgen Wagner, Prof. Dr. B.Braun Avitum AG
  More Information

No publications provided

Responsible Party: B.Braun Avitum AG
ClinicalTrials.gov Identifier: NCT01111266     History of Changes
Other Study ID Numbers: BA-I-H-09-02
Study First Received: April 15, 2010
Last Updated: March 13, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by B.Braun Avitum AG:
in vivo KUF
ß2M
leptin

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 28, 2014