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

NCT03714386 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2019-08-05

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

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

Sponsors & Collaborators

  • Fundación Senefro

    lead OTHER

Principal Investigators

  • Rafael Perez Garcia, PhD · Hospital Universitario Infanta Leonor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-03
Primary Completion
2021-12-31
Completion
2022-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03714386 on ClinicalTrials.gov