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OpenTrials
Completed

NCT Number: NCT01111266

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

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Key information

Conditions

Kidney Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georg-Haas Dialysezentrum der PHV

Giessen, Hesse, 35392, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xevonta

Device

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 outcomes

  1. 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.

Secondary outcomes

  1. Determination of removal rates

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

B.Braun Avitum AG

Industry

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Apr 27, 2010
Registry last updated
Mar 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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