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

Fundación Senefro700 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

700

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario Infanta Leonor

Madrid, Spain

RECRUITING

Outcomes

Primary Outcomes

Cardiovascular morbility

Occurring during the first 36 months after recruitment (consequence of dialisys) cardiovascular sintomatology (stroke, Acute Coronary Syndrome, Peripheral Arterial Disease, Ischemic Colitis.

Time frame: every 3 months

Central Contacts

Patricia de Sequera Ortiz, PhD

CONTACT

+34 911918000 psequerao@senefro.org

Data from ClinicalTrials.gov

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