Comparison of MCO HD on Markers of Vascular Health Compared With On-Line Haemodiafiltration
NCT ID: NCT03510520
Last Updated: 2019-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
63 participants
INTERVENTIONAL
2018-09-14
2019-05-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study will also compare the 2 treatment modalities with respect to several other outcome measures including patient-reported outcome measures, haemodynamic parameters and advanced glycation end-products.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration
NCT03448887
Exploratory Study to Explore the Safety and Efficacy of the HDx Therapy Using Theranova 500 Dialyzer in Comparison to Hemodiafiltration
NCT03499691
Theranova Randomized, Controlled, Trial (RCT) in China
NCT05309291
Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter
NCT03437538
Clinical Performance Comparison of 2 THERANOVA 400 Dialyzer Prototypes in HD With High-Flux Dialyzers in HD and hv HDF Mode
NCT02377622
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Medium cut-off (MCO) dialysis membranes have been recently developed to address this area of unmet need and provide an enhanced clearance of some larger middle molecules when compared with high flux haemodialysis (HFHD) and even high volume haemodiafiltration (HDF). The clinical benefit of this therapy is yet to be defined.
The aim of this study is to investigate the effect of HDx therapy (expanded haemodialysis therapy through the use of a MCO haemodialysis membrane- Theranova) on vascular endothelial and inflammatory biomarkers compared with high volume HDF therapy. Through the use of endothelial microvesicles (EMV) as a marker of vascular endothelial health, which strongly correlate with cardiovascular outcomes in end-stage real disease (ESRD) patients, this pilot study will take the first steps into exploring whether HDx treatment provides clinical benefits in addition to its simplicity of implementation. Additionally, other important parameters, such as dialysis recovery time, patient-reported outcome measures and volume management will also be explored and compared with high volume HDF.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Medium Cut-Off Haemodialysis (Theranova)
Participants will receive medium cut-off haemodialysis treatment for 6 months in total (3 times per week treatment).
Medium Cut-Off Haemodialysis
Treatment with medium cut-off haemodialysis using the Theranova dialysis membrane 3 times per week for 6 months
On-Line Haemodiafiltration
Participant will remain on their usual on-line haemodiafiltration (HDF) treatment for the 6 month study duration (3 times per week treatment).
On-Line Haemodiafiltration
Treatment with on-line haemodiafiltration (HDF) 3 times per week for 6 months (Conventional treatment)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Medium Cut-Off Haemodialysis
Treatment with medium cut-off haemodialysis using the Theranova dialysis membrane 3 times per week for 6 months
On-Line Haemodiafiltration
Treatment with on-line haemodiafiltration (HDF) 3 times per week for 6 months (Conventional treatment)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ability to consent
Exclusion Criteria
* Planned switch in renal replacement modality (ie. to peritoneal dialysis or home haemodialysis)
* Clinician predicted prognosis \< 6 months
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Manchester Metropolitan University
OTHER
Baxter Healthcare Corporation
INDUSTRY
Manchester University NHS Foundation Trust
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sandip Mitra, MBBS
Role: PRINCIPAL_INVESTIGATOR
Manchester University NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Manchester NHS Foundation Trust
Manchester, Lancashire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
R04863
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.