End Stage Renal Disease (ESRD)REMOV-HDxNCT07348536
Expanded Hemodialysis Versus High-Volume Online Hemodiafiltration for Uremic Toxin Removal
A study testing Expanded Hemodialysis With Medium Cut-Off Membrane and High-Volume Online Hemodiafiltration in people with End Stage Renal Disease (ESRD) and Chronic Kidney Disease on Hemodialysis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
People with advanced kidney disease need dialysis to remove waste products from the blood. Some of these waste products, called uremic toxins, are small, while others are medium-sized and more difficult to remove. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease (ESRD), Chronic Kidney Disease on Hemodialysis, Renal Dialysis
- What is being tested?
- Expanded Hemodialysis With Medium Cut-Off Membrane and High-Volume Online Hemodiafiltration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Vascular access unable to support a blood flow of at least 300 mL/min
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran
Mexico City, Mexico City, 14080
About this study
Official title: Impact of Expanded Hemodialysis Prescription on Global Uremic Toxin Removal Compared With High-Volume Online Hemodiafiltration: A Randomized Open-Label Crossover Study
People with advanced kidney disease need dialysis to remove waste products from the blood. Some of these waste products, called uremic toxins, are small, while others are medium-sized and more difficult to remove. Poor removal of these toxins may contribute to symptoms and long-term complications in patients on dialysis.
Two dialysis techniques are commonly used to improve toxin removal beyond standard hemodialysis: expanded hemodialysis (HDx) using medium cut-off membranes, and high-volume online hemodiafiltration (HV-OL-HDF). Although both techniques are effective, the best way to prescribe expanded hemodialysis-particularly the ideal treatment time-has not been clearly defined.
Read more
The purpose of this study is to compare how well different treatment times of expanded hemodialysis remove small and medium-sized uremic toxins, and to compare these results with high-volume online hemodiafiltration. Toxin removal will be evaluated using a combined measurement called the Global Removal Score, which summarizes the removal of several important waste substances.
This is a single-center, randomized, open-label, crossover study. Adults receiving maintenance hemodialysis will receive three different expanded hemodialysis sessions with different treatment durations (180, 210, and 240 minutes), followed by one session of high-volume online hemodiafiltration. Blood samples will be taken before and after each dialysis session to measure toxin levels.
The results of this study may help determine whether expanded hemodialysis with shorter or standard treatment times can achieve toxin removal similar to high-volume hemodiafiltration, which could support more personalized and practical dialysis prescriptions.
Read the detailed description
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.
- Conditions
- End Stage Renal Disease (ESRD), Chronic Kidney Disease on Hemodialysis, Renal Dialysis, Uremia; Chronic, Hemodialysis, Hemodiafiltration
- Being tested
- Expanded Hemodialysis With Medium Cut-Off Membrane, High-Volume Online Hemodiafiltration
- Keywords
- Expanded hemodialysis, High-volume online hemodiafiltration, Medium cut-off dialysis membranes, Uremic toxin removal, Middle molecule clearance, Chronic kidney failure, Dialysis dose optimization, Dialysis treatment time, Global removal score
- Medical subject headings
- Kidney Failure, Chronic, Uremia, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded Hemodialysis With Medium Cut-Off MembraneDevice
Also called Expanded hemodialysis, Medium cut-off hemodialysis
Expanded hemodialysis will be performed using a medium cut-off dialysis membrane designed to enhance the removal of medium-sized uremic toxins while preserving albumin. Treatments will be delivered during regularly scheduled dialysis sessions with fixed dialysate flow and the maximum blood flow tolerated by the participant. Each participant will receive expanded hemodialysis sessions with three different treatment durations (180, 210, and 240 minutes), administered in randomized order following the long interdialytic interval. Blood samples will be collected before and after each session to assess removal of small and medium-sized uremic toxins.
High-Volume Online HemodiafiltrationDevice
Also called Online hemodiafiltration, High-volume hemodiafiltration, Post-dilution online hemodiafiltration
High-volume online hemodiafiltration will be delivered using post-dilution substitution during a standard dialysis session. Treatment will target a predefined convective volume consistent with high-volume hemodiafiltration while maintaining standard dialysis safety parameters. This intervention will be administered once to each participant after completion of the expanded hemodialysis sessions. Blood samples will be collected before and after the session to measure removal of small and medium-sized uremic toxins for comparison with expanded hemodialysis.
| Study group | Role | What they receive |
|---|---|---|
| Expanded Hemodialysis Prescriptions and High-Volume Online Hemodiafiltration | Experimental | Participants will receive three expanded hemodialysis sessions with different treatment durations (180, 210, and 240 minutes) in randomized order, followed by one session of high-volume online hemodiafiltration. Blood samples will be collected before and after each session to assess uremic toxin removal. Receives: Device: Expanded Hemodialysis With Medium Cut-Off Membrane; Device: High-Volume Online Hemodiafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Removal Score of Uremic Toxins
The Global Removal Score is a composite measure of dialysis efficiency that summarizes the percentage reduction of selected small and medium-sized uremic toxins during a dialysis session. It is calculated using the reduction ratios of urea, beta-2 microglobulin, myoglobin, prolactin, alpha-1 microglobulin, and alpha-1 acid glycoprotein, adjusted for albumin loss. Higher values indicate greater overall uremic toxin removal.
Measured: During each dialysis intervention session (pre- and post-dialysis measurements), over a 4-week study period
Secondary outcomes (3)
Removal Rate of Individual Medium-Sized Uremic Toxins
Percentage reduction of individual medium-sized uremic toxins, including beta-2 microglobulin, myoglobin, prolactin, alpha-1 microglobulin, and alpha-1 acid glycoprotein, measured before and after each dialysis session.
Measured: During each dialysis intervention session (pre- and post-dialysis measurements), over a 4-week study period
Removal Rate of Small Solutes
Percentage reduction of small solutes, including urea and creatinine, measured before and after each dialysis session to assess small-molecule clearance across dialysis modalities and treatment durations.
Measured: During each dialysis intervention session (pre- and post-dialysis measurements), over a 4-week study period
Beta-2 Microglobulin Clearance by Kt/V
Dialysis dose for beta-2 microglobulin expressed as Kt/V, calculated for each dialysis session to compare the kinetics of beta-2 microglobulin removal across expanded hemodialysis prescriptions and high-volume online hemodiafiltration.
Measured: During each dialysis intervention session, over a 4-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olynka Vega, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Olynka Vega, MS, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348536
- Sponsor's protocol ID
- NMM-4853
- Acronym
- REMOV-HDx
- Status last verified
- Mar 2026
- First submitted
- 22 Dec 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. This study involves a small, single-center cohort with detailed clinical and laboratory data, and sharing individual-level data could increase the risk of participant re-identification. In addition, the data are collected for a specific mechanistic research purpose and are not intended for secondary analyses outside the scope of the approved protocol. Aggregate results will be reported through scientific publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Expanded Hemodialysis Prescription on Global Uremic Toxin Removal Compared With High-Volume Online Hemodiafiltration: A Randomized Open-Label Crossover Study
- ClinicalTrials.gov ID
- NCT07348536
- Acronym / sponsor ID
- REMOV-HDx / NMM-4853
- Conditions
- End Stage Renal Disease (ESRD), Chronic Kidney Disease on Hemodialysis, Renal Dialysis, Uremia; Chronic, Hemodialysis, Hemodiafiltration
- Keywords
- Expanded hemodialysis, High-volume online hemodiafiltration, Medium cut-off dialysis membranes, Uremic toxin removal, Middle molecule clearance, Chronic kidney failure, Dialysis dose optimization, Dialysis treatment time
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with advanced kidney disease need dialysis to remove waste products from the blood. Some of these waste products, called uremic toxins, are small, while others are medium-sized and more difficult to remove. Poor removal of these toxins may contribute to symptoms and long-term complications in patients on dialysis.
Two dialysis techniques are commonly used to improve toxin removal beyond standard hemodialysis: expanded hemodialysis (HDx) using medium cut-off membranes, and high-volume online hemodiafiltration (HV-OL-HDF). Although both techniques are effective, the best way to prescribe expanded hemodialysis-particularly the ideal treatment time-has not been clearly defined.
The purpose of this study is to compare how well different treatment times of expanded hemodialysis remove small and medium-sized uremic toxins, and to compare these results with high-volume online hemodiafiltration. Toxin removal will be evaluated using a combined measurement called the Global Removal Score, which summarizes the removal of several important waste substances.
This is a single-center, randomized, open-label, crossover study. Adults receiving maintenance hemodialysis will receive three different expanded hemodialysis sessions with different treatment durations (180, 210, and 240 minutes), followed by one session of high-volume online hemodiafiltration. Blood samples will be taken before and after each dialysis session to measure toxin levels.
The results of this study may help determine whether expanded hemodialysis with shorter or standard treatment times can achieve toxin removal similar to high-volume hemodiafiltration, which could support more personalized and practical dialysis prescriptions.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expanded Hemodialysis Prescriptions and High-Volume Online Hemodiafiltration | Experimental | Device: Expanded Hemodialysis With Medium Cut-Off Membrane, Device: High-Volume Online HemodiafiltrationParticipants will receive three expanded hemodialysis sessions with different treatment durations (180, 210, and 240 minutes) in randomized order, followed by one session of high-volume online hemodiafiltration. Blood samples will be collected before and after each session to assess uremic toxin removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Vascular access unable to support a blood flow of at least 300 mL/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expanded Hemodialysis With Medium Cut-Off MembraneAlso: Expanded hemodialysis, Medium cut-off hemodialysisExpanded hemodialysis will be performed using a medium cut-off dialysis membrane designed to enhance the removal of medium-sized uremic toxins while preserving albumin. Treatments will be delivered during regularly scheduled dialysis sessions with fixed dialysate flow and the maximum blood flow tolerated by the participant. Each participant will receive expanded hemodialysis sessions with three different treatment durations (180, 210, and 240 minutes), administered in randomized order following the long interdialytic interval. Blood samples will be collected before and after each session to assess removal of small and medium-sized uremic toxins. | Device | Expanded Hemodialysis Prescriptions and High-Volume Online Hemodiafiltration |
| High-Volume Online HemodiafiltrationAlso: Online hemodiafiltration, High-volume hemodiafiltration, Post-dilution online hemodiafiltrationHigh-volume online hemodiafiltration will be delivered using post-dilution substitution during a standard dialysis session. Treatment will target a predefined convective volume consistent with high-volume hemodiafiltration while maintaining standard dialysis safety parameters. This intervention will be administered once to each participant after completion of the expanded hemodialysis sessions. Blood samples will be collected before and after the session to measure removal of small and medium-sized uremic toxins for comparison with expanded hemodialysis. | Device | Expanded Hemodialysis Prescriptions and High-Volume Online Hemodiafiltration |
Primary outcome
Global Removal Score of Uremic Toxins
Time frame: During each dialysis intervention session (pre- and post-dialysis measurements), over a 4-week study period
The Global Removal Score is a composite measure of dialysis efficiency that summarizes the percentage reduction of selected small and medium-sized uremic toxins during a dialysis session. It is calculated using the reduction ratios of urea, beta-2 microglobulin, myoglobin, prolactin, alpha-1 microglobulin, and alpha-1 acid glycoprotein, adjusted for albumin loss. Higher values indicate greater overall uremic toxin removal.
3 secondary outcomes
Removal Rate of Individual Medium-Sized Uremic Toxins
Time frame: During each dialysis intervention session (pre- and post-dialysis measurements), over a 4-week study period
Removal Rate of Small Solutes
Time frame: During each dialysis intervention session (pre- and post-dialysis measurements), over a 4-week study period
Beta-2 Microglobulin Clearance by Kt/V
Time frame: During each dialysis intervention session, over a 4-week study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. This study involves a small, single-center cohort with detailed clinical and laboratory data, and sharing individual-level data could increase the risk of participant re-identification. In addition, the data are collected for a specific mechanistic research purpose and are not intended for secondary analyses outside the scope of the approved protocol. Aggregate results will be reported through scientific publications and presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olynka Vega, MS principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expanded Hemodialysis With Medium Cut-Off Membrane and High-Volume Online Hemodiafiltration in people with End Stage Renal Disease (ESRD) and Chronic Kidney Disease on Hemodialysis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olynka Vega, MS (+52 55 5487 0900 ext. 5606, olynka.vegav@incmnsz.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Removal Score of Uremic Toxins (time frame: During each dialysis intervention session (pre- and post-dialysis measurements), over a 4-week study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.