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| Name | Class |
|---|---|
| Winicker Norimed GmbH | INDUSTRY |
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The main purpose of this study is the determination of the in-vivo ultrafiltration coefficient (in-vivo KUF) for Diacap Pro dialyzers following routine dialysis prescription in the United States.
The in-vivo KUF for Diacap Pro High Flux dialysers with the surface sizes of 1.3/ 1.6/ 1.9 sqm will be determined as required by the US guideline "Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers 1998" for comparison with the in-vitro KUF data.
Clinical data of at least 12 patients will be collected for determination of the in-vivo KUF complemented by safety-, performance-data for the removal of small and middle molecular substances and hemocompatibility data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diacap Pro High-Flux | Experimental | 1.3/ 1.6/ 1.9 sqm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diacap Pro High-Flux | Device | During dialysis treatment ultrafiltration rate will be changed following a fixed schedule and resulting changes in Transmembrane Pressure (TMP) recorded to generate data for calculation of the in-vivo KUF. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Transmembrane Pressure (TMP) dependent on differerent ultrafiltration rates for calculation of the in-vivo ultrafiltration coefficient (in-vivo KUF) | UF-rates will be changed over a range starting from 600 ml/min to 1000 ml/min to 1400 ml/min to finally 1800 ml/min and resulting changes in Transmembrane Pressure (TMP) will be documented. | For two of three dialysis sessions each week for a total study period of six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance data dialyzer [ml/min] | For ß2M; Myoglobin; Retinol-Binding-Protein; alpha-1-Microglobulin; Albumin clearance data will be assessed by using serum samples pre- and post dialyzer at timepoints t=0 and t=240 min. | For one of six dialysis sessions each two weeks for a total study period of six weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Polakovic, Prim. MUDr. | Interni oddeleni Strahov VFN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Interní oddělení Strahov VFN | Prague | 169 00 Praha 6 | Czechia |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 22, 2020 | |
| Reset | Nov 13, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 22, 2020 | Nov 13, 2020 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Reduction rates dialyzer [%] |
For urea; creatinine; phosphate; ß2-Microglobulin; Myoglobin; Retinol-Binding-Protein; alpha-1 Microglobulin and Albumin reduction rates will be calculated by using serum-levels at timepoints t=0 and t=240 min. |
| For two of three dialysis sessions each week for a total study period of six weeks |
| Total removal of proteins [mg/session] | Spent dialysate will be collected during the entire dialysis treatment. Considering dialysate flow rate and ultrafiltration volume concentration of ß2-Microglobulin; Myoglobin; Retinol-Binding-Protein;alpha-1 Microglobulin; Albumin; Total Protein will be used to calculate total removal by multiplying with the effective spent dialysate volume | For one of six dialysis sessions each two weeks for a total study period of six weeks |
| Complement-activation C3a and C5a [ng/ml] | For complement activation C3a [ng/ml]; C5a [ng/ml] will be assessed at timepoints t=0, t=15; t=60; t=240 min. | For one of six dialysis sessions each two weeks for a total study period of six weeks |
| Complement-activation TAT III [µg/l] | For complement activation TAT III [µg/l] will be assessed at timepoints t=0, t=15; t=60; t=240 min. | For one of six dialysis sessions each two weeks for a total study period of six weeks |
| Inflammatory response Interleukin-1, Interleukin-6 and TNF-alpha [pg/ml] | For inflammatory response Interleukin-1 [pg/ml]; Interleukin-6 [pg/ml]; TNF-alpha will be assessed at timepoints t=0; t=15; t=60; t=240 min | For one of six dialysis sessions each two weeks for a total study period of six weeks |
| Inflammatory response CRP [mg/l] | For inflammatory response CRP[mg/l] will be assessed at timepoints t=0; t=15; t=60; t=240 min | For one of six dialysis sessions each two weeks for a total study period of six weeks |
| Incidence of Treatment-Emergent Adverse Events | Number of patients presenting adverse events will be assessed following CTCAE v4.0 grading. | November 2016 up to 2 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |