RecruitingNot ApplicableNCT07348536

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

Impact of Expanded Hemodialysis Prescription on Global Uremic Toxin Removal Compared With High-Volume Online Hemodiafiltration: A Randomized Open-Label Crossover Study


Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Enrollment

15 participants

Start Date

Aug 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of kidney dialysis — expanded hemodialysis (HDx) and high-volume online hemodiafiltration (HDF) — to see which is better at removing waste products (called uremic toxins) that build up in the blood when the kidneys fail. Some of these toxins are harder to remove with standard dialysis. **You may be eligible if...** - You are 18 or older - You have end-stage kidney disease (kidney failure) - You are currently on expanded hemodialysis (HDx) three times per week as part of your routine care for at least 1 month - You have been on dialysis for more than 3 months overall - You produce little to no urine (less than 100 mL per day) **You may NOT be eligible if...** - Your blood vessel access (e.g., fistula or catheter) cannot support a blood flow of at least 300 mL/min during dialysis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHigh-Volume 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.

DEVICEExpanded Hemodialysis With Medium Cut-Off Membrane

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.


Locations(1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran

Mexico City, Mexico City, Mexico

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NCT07348536


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