Expanded Hemodialysis Versus High-Volume Online Hemodiafiltration for Uremic Toxin Removal

NCT07348536 | Not Yet Recruiting

• 1 other identifier: NMM-4853
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hemodiafiltration; Chronic Kidney Disease on Hemodialysis; End Stage Renal Disease (ESRD); Renal Dialysis; Uremia; Chronic; Hemodialysis

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  During each dialysis intervention session (pre- and post-dialysis measurements), over a 4-week study period

• Removal Rate of Small Solutes

  During each dialysis intervention session (pre- and post-dialysis measurements), over a 4-week study period

• Beta-2 Microglobulin Clearance by Kt/V

  During each dialysis intervention session, over a 4-week study period

Study Arms (1)

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.

Device: Expanded Hemodialysis With Medium Cut-Off Membrane; Device: High-Volume Online Hemodiafiltration

Interventions

Expanded Hemodialysis With Medium Cut-Off Membrane DEVICE

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.

Also known as: Expanded hemodialysis, Medium cut-off hemodialysis

Expanded Hemodialysis Prescriptions and High-Volume Online Hemodiafiltration

High-Volume Online Hemodiafiltration DEVICE

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.

Also known as: Online hemodiafiltration, High-volume hemodiafiltration, Post-dilution online hemodiafiltration

Expanded Hemodialysis Prescriptions and High-Volume Online Hemodiafiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Vascular access unable to support a blood flow of at least 300 mL/min

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran

Mexico City, Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Uremia; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Olynka Vega, MS

  Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olynka Vega, MS

CONTACT

+52 55 5487 0900; olynka.vegav@incmnsz.mx

Erick Yasar Zuñiga, MD

CONTACT

+52 55 5487 0900; erick.zunigag@incmnsz.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 16, 2026
• Study Start: April 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)