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| Name | Class |
|---|---|
| Labor Limbach, Heidelberg, Germany | UNKNOWN |
| Clin-Sol, Würzburg, Germany | UNKNOWN |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| in vivo KUF | 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of removal rates | Removal rates for urea, phosphate, creatinine, albumin, leptin and Beta2-microglobulin will be determined. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jürgen Wagner, Prof. Dr. | B.Braun Avitum AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georg-Haas Dialysezentrum der PHV | Giessen | Hesse | 35392 | Germany |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| D052801 | Male Urogenital Diseases |