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

Not Applicable

• Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
• Interventions: Device: A medium cut-off dialyzer will be used for HDx.; Device: A synthetic high-flux dialyzer will be used for OL-HDF.

• Registration Number: NCT03714386
• Lead Sponsor: Fundación Senefro

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-10-19
• Study First Posted: 2018-10-22
• Status Verified: 2019-04
• Study Start: 2019-04-03
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-05
• Primary Completion: 2021-12
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
expanded hemodialysis (HDx)	A medium cut-off dialyzer will be used for HDx.	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)	A synthetic high-flux dialyzer will be used for OL-HDF.	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

Primary Outcome Measures

Name	Time	Method
Cardiovascular morbility	every 3 months	Occurring during the first 36 months after recruitment (consequence of dialisys) cardiovascular sintomatology (stroke, Acute Coronary Syndrome, Peripheral Arterial Disease, Ischemic Colitis.

Trial Locations

Locations (1)

Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Spain