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study to evaluate the safety and efficacy of Expanded Hemodialysis (HDx) compared to hemodiafiltration (HDF) in patients with chronic kidney disease in Spain for up to 36 months.
Approximately 700 patients will be included.
This is an open-label, prospective, 1:1 randomized, parallel-group, study to evaluate the safety and efficacy of Expanded Hemodialysis (HDx) compared to hemodiafiltration (HDF) in patients with chronic kidney disease in Spain for up to 36 months.
Stable incident hemodialysis patients from hemodialysis in-hospital units and related satellite centers in Spain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| expanded hemodialysis (HDx) | Experimental | HDx therapies must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription |
|
| online hemodiafiltration (HDF-OL) | Active Comparator | OL-HDF therapies must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A synthetic high-flux dialyzer will be used for OL-HDF. | Device | A synthetic high-flux dialyzer used for OL-HDF must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular morbility | Occurring during the first 36 months after recruitment (consequence of dialisys) cardiovascular sintomatology (stroke, Acute Coronary Syndrome, Peripheral Arterial Disease, Ischemic Colitis. | every 3 months |
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Inclusion Criteria:
Exclusion Criteria:
>18 years
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia de Sequera Ortiz, PhD | Contact | +34 911918000 | psequerao@senefro.org |
| Name | Affiliation | Role |
|---|---|---|
| Rafael Perez Garcia, PhD | Hospital Universitario Infanta Leonor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Infanta Leonor | Recruiting | Madrid | 28031 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40577061 | Derived | Blankestijn PJ. Do Medium Cut-Off Dialyzers Offer Any Clinical Benefit or Should We Focus on Hemodiafiltration? J Am Soc Nephrol. 2025 Jun 27;36(8):1473-1475. doi: 10.1681/ASN.0000000777. No abstract available. |
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|
| A medium cut-off dialyzer will be used for HDx. | Device | A medium cut-off dialyzer used for HDx must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription |
|