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

Launched by FUNDACIÓN SENEFRO · Oct 19, 2018

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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.