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

NCT ID: NCT01111266

Last Updated: 2012-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-03-31

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.

Conditions

Kidney Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Labor Limbach, Heidelberg, Germany

UNKNOWN

Sponsor Role: collaborator

Clin-Sol, Würzburg, Germany

UNKNOWN

Sponsor Role: collaborator

B.Braun Avitum AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jürgen Wagner, Prof. Dr.

Role: STUDY_DIRECTOR

B.Braun Avitum AG

Locations

Georg-Haas Dialysezentrum der PHV

Giessen, Hesse, Germany

Countries

Germany

Other Identifiers

BA-I-H-09-02

Identifier Type: -

Identifier Source: org_study_id