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

  • STATUS
    Recruiting
  • End date
    Mar 23, 2022
  • participants needed
    700
  • sponsor
    Fundación Senefro
Updated on 23 January 2021

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.

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.

Details
Condition Chronic Kidney Disease Requiring Chronic Dialysis
Treatment A synthetic high-flux dialyzer will be used for OL-HDF., A medium cut-off dialyzer will be used for HDx.
Clinical Study IdentifierNCT03714386
SponsorFundación Senefro
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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