NCT03714386

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

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Fundación Senefro · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

Type	Name	Description
DEVICE	A synthetic high-flux dialyzer will be used for OL-HDF.	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
DEVICE	A medium cut-off dialyzer will be used for HDx.	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

Timeline

• Start date: 2019-04-03
• Primary completion: 2021-12-01
• Completion: 2022-03-01
• First posted: 2018-10-22
• Last updated: 2019-08-05

Locations

1 site across 1 country: Spain