Study to Explore Morbimortality in Patients Dialyzed With the Theranova HDx in Comparison to On-Line-Hemodiafiltration

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicentre, Open-label, Prospective, Randomized Study to Explore the Morbimortality in Patients Dialyzed With the Theranova HDx in Comparison to On-Line - Hemodiafiltration (Study MoTHER HDx)

Conditions
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Chronic Kidney Disease Requiring Chronic Dialysis

Intervention / Treatment
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* Device: A synthetic high-flux dialyzer will be used for OL-HDF.
* Device: A medium cut-off dialyzer will be used for HDx.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: End stage Renal Disease (ESRD) patients Age> 18 years old HD therapy three times per week for 3 months at least and a maximum of 24 months. Exclusion Criteria: No informed consent provided Synthetic membrane allergy Pregnant, breastfeeding, or planning to become pregnant Active systemic diseases: liver cirrhosis, malignancy prior to enrollment (except basal cell skin or similar) and / or immunosuppressive treatment in the 3 months before the recruitment. Scheduled for living-donor transplantation within the study period Patients with a significant residual renal function (defined as Urea clearance >2,5 ml/min. Currently participating in another interventional clinical study or has participated in another interventional clinical study in the last 3 months that may interfere with this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: expanded hemodialysis (HDx)<br>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 | Device: A medium cut-off dialyzer will be used for HDx.<br>* 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<br>|
| Active Comparator: online hemodiafiltration (HDF-OL)<br>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 | Device: A synthetic high-flux dialyzer will be used for OL-HDF.<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |