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

Chronic Kidney Disease Requiring Chronic Dialysis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03714386
• Other study ID #: MoTHER HDx
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2019
• Est. completion date: March 2022

Study information

• Verified date: April 2019
• Source: Fundación Senefro
• Contact: Patricia de Sequera Ortiz, PhD
• Phone: +34 911918000
• Email: psequerao[@]senefro.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease Requiring Chronic Dialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Hospital Universitario Infanta Leonor	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Senefro

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular morbility	Occurring during the first 36 months after recruitment (consequence of dialisys) cardiovascular sintomatology (stroke, Acute Coronary Syndrome, Peripheral Arterial Disease, Ischemic Colitis.	every 3 months