Expanded Hemodialysis Versus High-Volume Online Hemodiafiltration for Uremic Toxin Removal
15 patients around the world
Available in Mexico
Expanded hemodialysis (HDx) using medium cut-off (MCO) membranes has been developed to
improve the removal of medium-sized uremic toxins while maintaining effective clearance
of small solutes. These medium-sized molecules have been associated with inflammation,
cardiovascular disease, and other complications in patients with end-stage kidney
disease. High-volume online hemodiafiltration (HV-OL-HDF) is currently considered a
reference therapy for enhanced removal of these toxins, but its use may be limited by
technical requirements, vascular access constraints, or resource availability.
While expanded hemodialysis has shown removal efficiency comparable to high-volume
hemodiafiltration in prior studies, the optimal prescription of HDx-particularly the
appropriate treatment duration-has not been clearly established. In routine clinical
practice, dialysis dose is commonly guided by small-solute clearance (such as urea),
which may not fully reflect the removal of medium-sized uremic toxins. A more
comprehensive evaluation of toxin removal may help optimize dialysis prescriptions and
improve treatment personalization.
This study is designed to compare the efficiency of uremic toxin removal across different
expanded hemodialysis treatment durations and to contrast these results with high-volume
online hemodiafiltration. Removal efficiency will be assessed using the Global Removal
Score, a composite measure that integrates the removal rates of several small and
medium-sized molecules while accounting for albumin loss.
The study is a single-center, randomized, open-label, crossover trial conducted in adult
patients receiving maintenance hemodialysis. Each participant will receive three expanded
hemodialysis sessions with different treatment durations (180, 210, and 240 minutes),
administered in randomized sequences following the long interdialytic interval. After
completion of the three expanded hemodialysis sessions, all participants will undergo one
session of high-volume online hemodiafiltration with a predefined convective volume
target.
During each study session, blood samples will be collected immediately before and after
dialysis to measure concentrations of selected uremic toxins, including small solutes and
medium-sized molecules. These measurements will be used to calculate individual and
global removal rates for each dialysis modality and treatment duration. Standard dialysis
parameters will be maintained according to institutional practice to ensure patient
safety and consistency across sessions.
The crossover design allows each participant to serve as their own control, reducing
variability related to patient-specific factors. The primary analysis will compare global
toxin removal between expanded hemodialysis prescriptions and high-volume online
hemodiafiltration, as well as across different HDx treatment durations.
The findings of this study may help clarify whether expanded hemodialysis with shorter or
standard treatment times can achieve toxin removal comparable to high-volume
hemodiafiltration. This information could support more individualized dialysis
prescriptions and inform clinical decision-making in settings where high-volume
hemodiafiltration is not feasible or routinely available.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1Research sites
15Patients around the world
This study is for people with
Renal disease
End-stage renal disease
Requirements for the patient
From 18 Years
All Gender
Medical requirements
Adults aged 18 years or older.
End stage renal disease Receiving maintenance hemodialysis three times per week on expanded hemodialysis as part of routine care for at least 1 month.
On dialysis treatment for more than 3 months.
Minimal or no residual urine output (less than 100 mL per day).
Able and willing to provide written informed consent.
Vascular access unable to support a blood flow of at least 300 mL/min.
Sites
Instituto Nacional de Ciencias Médicas y Nutrición Dr. Salvador Zubirán
Vasco de Quiroga 15, Belisario Domínguez Secc 16, 14080 Ciudad de México
StudyREMOV-HDx
SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran