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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01111266

Enrollment

Registered

2010-04-27

Start date

2010-03-31

Completion date

2012-03-31

Last updated

2012-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Disease

Keywords

in vivo KUF, ß2M, leptin

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.

Interventions

DEVICExevonta

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
in vivo KUF	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

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026