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

Fundación Senefro

Status: Unknown

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

Treatments: Device: A synthetic high-flux dialyzer will be used for OL-HDF.; Device: A medium cut-off dialyzer will be used for HDx.

Study type: Interventional

Funder types: Other

Identifiers

NCT03714386

MoTHER HDx

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 2 patient groups

expanded hemodialysis (HDx)

Experimental group

Description:

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

Treatment:

Device: A medium cut-off dialyzer will be used for HDx.

online hemodiafiltration (HDF-OL)

Active Comparator group

Description:

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

Treatment:

Device: A synthetic high-flux dialyzer will be used for OL-HDF.