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

NCT01111266 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-03-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Labor Limbach, Heidelberg, Germany

    collaborator UNKNOWN

  • Clin-Sol, Würzburg, Germany

    collaborator UNKNOWN

  • B.Braun Avitum AG

    lead INDUSTRY

Principal Investigators

  • Jürgen Wagner, Prof. Dr. · B.Braun Avitum AG

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-08-31
Completion
2012-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01111266 on ClinicalTrials.gov