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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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The study investigates the performance of a new dialyzer (Theranova 400) containing a membrane with increased pore sizes. The performance will be determined by the removal of middle molecules (with different molecular size) from the blood compartment. Two different Theranova 400 prototypes (AA and BB) operated in hemodialysis mode will be compared with a Cordiax Fx-80 dialyzer, operated in hemodialysis mode, and with a Cordiax Fx-800, operated in high volume hemodiafiltration mode. Safety events and albumin loss into the dialysate will be monitored
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THERANOVA 400 dialyzer prototype AA | Experimental | THERANOVA 400 dialyzer prototype AA in hemodialysis |
|
| THERANOVA 400 dialyzer prototype BB | Experimental | THERANOVA 400 dialyzer prototype BB in hemodialysis |
|
| FX CorDiax 80 dialyzer | Active Comparator | FX CorDiax 80 dialyzer in hemodialysis |
|
| FX CorDiax 800 dialyzer | Active Comparator | FX CorDiax 800 dialyzer in high volume hemodiafiltration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THERANOVA 400 dialyzer prototype AA | Device |
| ||
| THERANOVA 400 dialyzer prototype BB |
| Measure | Description | Time Frame |
|---|---|---|
| Overall clearance of lambda FLC clearance | Blood and dialysate | Five (5) hours ( for each mid-week dialysis session) |
| Overall albumin loss | Dialysate | Five (5) hours (for each mid-week dialysis session) |
| Measure | Description | Time Frame |
|---|---|---|
| Types and frequency of adverse events and device deficiencies as a measure of safety and dialyzer tolerability | All adverse events and device deficiencies will be recorded | Average 60 days (continuously, from signature of informed consent form until 1 week after last hemodialysis session with an experimental or active comparator product) |
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Inclusion Criteria:
6. Patient has a stable functioning native fistula 7. Patient is willing to comply with the study requirements for therapy during the entire study treatment period 8. Patient is capable fo providing written informed consent to participate in the study
Exclusion Criteria:
Patient is undergoing single-needle dialysis
Patient has an known abnormal k/λ ratio (less than 0.37, or greater than 3.1)
Patient has a known active infection and is currently receiving antibiotic treatment
Patient has known active cancer
Patient has a known positive serology test for human immunodeficiency virus (HIV) or hepatitis B,C or E
Patient has a known serious hemostasis disorder
Patient has a known monoclonal gammopathy
Patient has a known polyclonal gammopathy
Patient has a unstable condition as judged by the treating physician based on medical history, physical examination and laboratory testing including (but not limited to) any of the following:
Patient has any other known comorbidity that could, in the opinion of the Investigator, potentially conflict with the study purpose or procedure
Patient has a known significant psychiatric disorder or mental disability that could interfere with the patient's ability to provide informed consent and/or comply with protocol procedures
Patient has a history of non-compliance with the dialysis prescription, as assessed by the Investigator
Patient has participated in another interventional clinical study in the past 3 months, or is currently participating in another interventional clinical study
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| Name | Affiliation | Role |
|---|---|---|
| Torsten Böhler, Manager | Life Sciences & Operations, Gambro Dialysatoren GmbH (a subsidiary of Baxter International Inc.) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dialysexentrum Elsenfeld | Elsenfeld | 63820 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27587605 | Result | Kirsch AH, Lyko R, Nilsson LG, Beck W, Amdahl M, Lechner P, Schneider A, Wanner C, Rosenkranz AR, Krieter DH. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172. doi: 10.1093/ndt/gfw310. | |
| 28910799 | Result | Kirsch AH, Rosenkranz AR, Lyko R, Krieter DH. Effects of Hemodialysis Therapy Using Dialyzers with Medium Cut-Off Membranes on Middle Molecules. Contrib Nephrol. 2017;191:158-167. doi: 10.1159/000479264. Epub 2017 Sep 14. |
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| Device |
|
| FX CorDiax 80 Dialyzer | Device |
|
| FX CorDiax 800 Dialyzer | Device |
|
| Clearance of other middle sized molecules |
Blood and dialysate |
| Five (5) hours (for each mid-week dialysis session) |
| Hematology ( blood cell counts; hematocrit and hemoglobin) | Blood | Five (5) hours ( for each mid-week dialysis session) |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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