Back to resultsStudy to Explore Morbimortality in Patients Dialyzed With the Theranova HDx in Comparison to On-Line-Hemodiafiltration
Primary Purpose
Chronic Kidney Disease Requiring Chronic Dialysis
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
A synthetic high-flux dialyzer will be used for OL-HDF.
A medium cut-off dialyzer will be used for HDx.
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease Requiring Chronic Dialysis
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.
Sites / Locations
- Hospital Universitario Infanta LeonorRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
expanded hemodialysis (HDx)
online hemodiafiltration (HDF-OL)
Arm 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
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
Outcomes
Primary Outcome Measures
Cardiovascular morbility
Occurring during the first 36 months after recruitment (consequence of dialisys) cardiovascular sintomatology (stroke, Acute Coronary Syndrome, Peripheral Arterial Disease, Ischemic Colitis.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03714386
Brief Title
Study to Explore Morbimortality in Patients Dialyzed With the Theranova HDx in Comparison to On-Line-Hemodiafiltration
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Senefro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Requiring Chronic Dialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
expanded hemodialysis (HDx)
Arm Type
Experimental
Arm 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
Arm Title
online hemodiafiltration (HDF-OL)
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
A synthetic high-flux dialyzer will be used for OL-HDF.
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
A medium cut-off dialyzer will be used for HDx.
Intervention Description
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
Primary Outcome Measure Information:
Title
Cardiovascular morbility
Description
Occurring during the first 36 months after recruitment (consequence of dialisys) cardiovascular sintomatology (stroke, Acute Coronary Syndrome, Peripheral Arterial Disease, Ischemic Colitis.
Time Frame
every 3 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
>18 years
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia de Sequera Ortiz, PhD
Phone
+34 911918000
Email
psequerao@senefro.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Perez Garcia, PhD
Organizational Affiliation
Hospital Universitario Infanta Leonor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia de Sequera Ortiz, PhD
First Name & Middle Initial & Last Name & Degree
Rafael Perez Garcia, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Explore Morbimortality in Patients Dialyzed With the Theranova HDx in Comparison to On-Line-Hemodiafiltration
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