Trials / Completed
CompletedNCT01111266
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- B.Braun Avitum AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2011-08-01
- Completion
- 2012-03-01
- First posted
- 2010-04-27
- Last updated
- 2012-03-14
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01111266. Inclusion in this directory is not an endorsement.