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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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Today it is well established that middle molecules comprise several compounds that are not effectively removed by high-flux dialyzers, and effective clearance of large middle molecules in the process of dialysis depends on the dialyzer membrane having large enough pore sizes, larger than the conventional high-flux dialyzers. Studies have found associations between levels of large middle molecule uremic toxins and immune dysfunction and inflammation, as well as adverse outcomes. This indicates that dialysis membranes having larger pores, enabling an expanded HD (HDx) with more effective removal of large middle molecules, can have a positive impact on the inflammatory state. While data is starting to appear on the long-term use of the HDx therapy, little is still known on how large middle molecules and inflammation markers are affected over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expanded Hemodialysis (HDx) Therapy | Experimental | Patients will undergo 3 dialysis sessions per week with Theranova 500 for up to 24 weeks. |
|
| Hemodiafiltration (HDF) Therapy | Active Comparator | Patients will undergo 3 dialysis sessions per week with on-line HDF for up to 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theranova 500 medium cut-off dialyzer | Device | The patients randomized in this group using the Theranova 500 medium cut-off dialyzer, and blood flow rate and treatment duration will be maintained stable during the observation period. However, other prescriptions will vary based on the Principal Investigator's (PI's) judgment. If other dialyzers need to be temporarily used during the study period it shall be recorded which alternative dialyzers are used and for how long the study patient is on a different dialyzer. However, prior to Week 12 laboratory assessment it is recommended that the patient undergoes three dialysis sessions on the designated treatment mode. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction ratios of lambda immunoglobulin free light chains (λ-FLC) | Week 12 | |
| Reduction ratios of kappa immunoglobulin free light chains (k-FLC) | Week 12 | |
| Reduction ratios of chitinase-3-like protein 1 (YKL-40) | Week 12 | |
| Reduction ratios of fibroblast growth factor 23 (FGF-23) | Week 12 | |
| Reduction ratios of serum beta-2 microglobulin (β2M) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mid-week pre-dialysis serum levels of λ-FLC, κ-FLC, YKL-40, FGF-23, ß2M | Week 12 and 24 | |
| Change from baseline in mid-week pre-dialysis serum levels of pentraxin-3 (PTX-3), high sensitivity C-reactive protein (hs-CRP), interleukin (IL-6), and interleukin-10 (IL-10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RTS Murcia VII, RTS Servicios de Diálisis S.L.U. | Murcia | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34125503 | Result | Hadad-Arrascue F, Nilsson LG, Rivera AS, Bernardo AA, Cabezuelo Romero JB. Expanded hemodialysis as effective alternative to on-line hemodiafiltration: A randomized mid-term clinical trial. Ther Apher Dial. 2022 Feb;26(1):37-44. doi: 10.1111/1744-9987.13700. Epub 2021 Jun 29. |
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|
| Hemodiafiltration | Device | The patients randomized in this group using the on-line high-flux HDF dialyzer, in post dilution mode, will continue to receive treatments according to their current treatment prescriptions for the duration of the study. |
|
| Week 12 and 24 |
| Percent change from pre- to post-dialysis in mid-week serum levels of hs-CRP | Week 12 |
| Percent change from pre- to post-dialysis in mid-week serum levels of PTX-3 | Week 12 |
| Percent change from pre- to post-dialysis in mid-week serum levels of IL-6 | Week 12 |
| Percent change from pre- to post-dialysis in mid-week serum levels of IL-10 | Week 12 |
| Change from baseline in mid-week pre-dialysis serum level of fibrinogen | Week 12 and 24 |
| Change from baseline in mid-week pre-dialysis serum level of albumin | Week 12 and 24 |
| Single pool Kt/Vurea | Week 24 |
| Serum phosphorous | Week 24 |
| Kidney Disease Quality of Life 36 (KDQOL-36) | Baseline, Week 12, Week 24 |
| Dialysis Symptom Index (DSI) | Baseline, Week 12, Week 24 |
| Serum ferritin | Baseline, Week 12, Week 24 |
| Transferrin Saturation (TSAT) | Baseline, Week 12, Week 24 |
| 24-hour urine output on monthly basis | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 |
| Erythropoiesis stimulating agent (ESA) responsiveness | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 |
| Hemoglobin levels | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 |
| ESA dosage by type, administration frequency, and route | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 |
| Intravenous iron dosage | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 |
| Number of adverse events of hospitalization, cardiovascular events, and infective episodes | Week 1 through Week 24 |
| Total patient death | Week 1 through Week 24 |
| 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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| ID | Term |
|---|---|
| D017583 | Hemodiafiltration |
| ID | Term |
|---|---|
| D006435 | Renal Dialysis |
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D006440 | Hemofiltration |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
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