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HighVolumeHDF Therapy:
Transforming the Standard of Kidney Care for Your Patients

HighVolumeHDF (HVHDF) or high-dose hemodiafiltration is an advanced form of hemodialysis (HD). Backed by decades of global experience and several randomized controlled trials, HVHDF therapy is now available for clinical use in the United States.

Potential Benefits of HighVolumeHDF Therapy Compared to Conventional HD

HighVolumeHDF provides patients the opportunity to live longer and feel better*

A landmark study, the CONVINCE Trial,† showed a 23% risk reduction in all-cause mortality for HVHDF compared with High-Flux HD.1 Real-world evidence from more than 80,000 patients showed a similar reduction in mortality risk.2

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Better preservation of quality of life1,3

HVHDF may contribute to better preservation of quality of life.1,3
  • Slower decline in cognitive and physical functions
  • Extended ability for social participation
  • Reduced interference with daily activities due to pain

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Reduced risk of intradialytic hypotensive episodes4,5‡

HVHDF has been associated with less cramping and intradialytic hypotension and better treatment tolerability.4,5

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Improved recovery time6,7‡

Some patients may experience less post-dialysis fatigue and shorter post-dialysis recovery time with HVHDF.6,7

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Reduced risk of hospitalization4,8‡

HVHDF may lower risk of hospitalizations due to infections or cardiovascular complications.4,8

Selection of dialysis modality should be based on individual patient needs, clinical judgment, and applicable clinical guidelines.

*Based on reduced mortality risk and slower decline in quality of life in patients treated with HVHDF compared to standard HD.1-3

†CONVINCE Trial Disclaimer: The CONVINCE Trial was an international pragmatic, randomized, controlled trial that compared all-cause mortality in European dialysis patients randomized to High-Flux HD or high-dose (≥23 ± 1 L convection volume / session) hemodiafiltration (HDF). The impact of high-dose HDF on the dialysis patients in the United States has not been evaluated and the results of this trial may not reflect outcomes with this therapy in the United States. The suitability of high-dose HDF for a given patient should be based on each patient's individual characteristics and is the sole responsibility of the attending physician. The CONVINCE Trial and other clinical studies supporting HighVolumeHDF were conducted outside of the United States and did not involve the 5008X™ CAREsystem.

‡Not all studies show the same outcome and not all patients will experience the same benefit.

How HighVolumeHDF Works

HVHDF combines diffusive and convective transport. This allows for enhanced clearance of a wider range of uremic toxins, including large middle molecules, while preserving vital proteins.

Post-dilution Online HDF:
Substitution Fluid After the Dialyzer

Convection Volume

Convection volume (i.e., total ultrafiltration volume) is the sum of the net ultrafiltration volume (i.e., the treatment-induced weight loss as calculated to estimate dry weight) and substitution volume.

Container representing X L Ultrafiltration (weight loss) plus Y L Substitution Fluid equals ≥ 23 L Convection Volume

Higher Convective Dose Correlates With Improved Outcomes9
    •  Online generation of sterile, non-pyrogenic substitution fluid enables high convective volumes, which are essential for enhanced convective transport
    •  HVHDF, with convection volumes of ≥23 liters per session, has been positively associated with improved patient outcomes9

Incorporating HighVolumeHDF Into Everyday Practice

HVHDF can be achieved in most in-center, end-stage kidney disease (ESKD) patients.8

Typical elements of a prescription

Assess vascular access adequacy and achievable blood flow rates

Automatic adaption of dialysate flow based on blood flow

Select a compatible dialyzer optimized for high-volume exchange

Prescribe manual or automated post-dilution HDF therapy

Review and adjust the dialysate prescription

Review and adjust the anticoagulation prescription

Comprehensive Resources and Support

Fresenius Medical Care is committed to providing support and dedicated resources for healthcare professionals interested in learning more about HVHDF.

Clinical Education and Training
  • Advanced Renal Education Program (AREP) is an online education platform offering comprehensive eLearning courses, expert presentation videos, and review articles

Medical Education
  • Medical Information Specialists can provide sample clinical protocols, expert guidance on prescription optimization, and direct access to Medical Science Liaisons for in-depth support
  • You can also learn from experts via educational webinars

Advanced, In-Center Dialysis: HCP Web Page
  • Learn how the 5008X™ CARESystem enables advanced, in-center dialysis care by providing both online HD and HVHDF. Visit 5008XCAREsystem.com

Advanced, In-Center Dialysis: Patient Web Page
  • Share information about HDF and the 5008X CAREsystem with your patients. Send them to MyHDFJourney.com to learn more

Stay Connected

Stay up to date with news and information regarding hemodiafiltration and HVHDF. Every issue highlights the newest publications, complete with concise summaries and key takeaways.

Disclaimer:

The CONVINCE study was exclusively supported by the European Commission Research & Innovation, Horizon 2020, Call H2020-SC1-2016-2017 under the topic SC1-PM-10-2017: Comparing the effectiveness of existing healthcare interventions in the audit population (grant no 754803).

The information in this document is provided as is and no guarantee or warranty is given that the information is fit for any particular purpose. The user thereof uses the information at its sole risk and liability. The opinions expressed in the document are of the authors only and in no way reflect the European Commission's opinions.

References:

1. Blankestijn PJ, Vernooij RWM, Hockman C, et al; on behalf of the CONVINCE Scientific Committee Investigators. Effect of hemodiafiltration or hemodialysis on mortality in kidney failure. N Engl J Med. 2023;389(8):700-709. https://doi.org/10.1056/NEJMoa2304820

2. Zhang Y, Winter A, Ferreras BA, et al. Real-world effectiveness of hemodialysis modalities: a retrospective cohort study. BMC Nephrol. 2025;26(1):9. https://doi.org/10.1186/s12882-024-03934-y

3. Rose M, Fischer FH, Liegl G, et al; on behalf of the CONVINCE Scientific Committee and CONVINCE Investigators. The CONVINCE randomized trial found positive effects on quality of life for patients with chronic kidney disease treated with hemodiafiltration. Kidney Int. 2024;106(5):961-971. https://doi.org/10.1016/j.kint.2024.07.014

4. Maduell F, Moreso F, Pons M, et al. High-efficiency postdilution online hemodiafiltration reduces all-cause mortality in hemodialysis patients. J Am Soc Nephrol. 2013;24(3):487-497. https://doi.org/10.1681/ASN.2012080875

5. Rootjes PA, Chaara S, de Roij van Zuijdewijn CLM, Nubé MJ, Wijngaarden G, Grooteman MPC. High-volume hemodiafiltration and cool hemodialysis have a beneficial effect on intradialytic hemodynamics: a randomized cross-over trial of four intermittent dialysis strategies. Kidney Int Rep. 2022;7(9):1980-1990. https://doi.org/10.1016/j.ekir.2022.06.021

6. Nenova DD, Chausheva GM, Yankov YG. Online hemodiafiltration: a new perspective for patients with end-stage renal disease. Cureus. 2024;16(8):e66076. https://doi.org/10.7759/cureus.66076

7. Karkar A, Abdelrahman M, Locatelli F. A randomized trial on health-related patient satisfaction level with high-efficiency online hemodiafiltration versus high-flux dialysis. Blood Purif. 2015;40(1):84-91. https://doi.org/10.1159/000381255

8. Zhang Y, Winter A, Ficociello LH, et al. Real-world hospitalization outcomes with on-line hemodiafiltration versus high-flux hemodialysis: a retrospective, international cohort study. Clin J Am Soc Nephrol. 2025;7(10):1692-1700. https://doi.org/10.2215/CJN.0000000955

9. Vernooij RWM, Hockham C, Strippoli G, et al; on behalf of the CONVINCE Scientific Committee and the HDF Pooling Project Investigators. Haemodiafiltration versus haemodialysis for kidney failure: an individual patient data meta-analysis of randomised controlled trials. Lancet. 2024;404(10464):1742-1749. https://doi.org/10.1016/S0140-6736(24)01859-2

Indications for Use:

Machine:

The 5008X™ system is indicated for intermittent hemodialysis treatment for patients with acute and chronic renal failure in a healthcare facility. Therapy options for patients weighing more than 40 kg include: Hemodiafiltration (HDF), Hemodialysis (HD), Hemofiltration (HF) and Isolated Ultrafiltration.

The 5008X Machine is equipped with a bibag® system, but it may also be used with liquid bicarbonate using the connector included with the machine. The bibag system is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. The bibag system is intended to be used as one component in the preparation of dialysate according to a physician's prescription in a 3-stream proportioning hemodialysis machine equipped with the bibag module.

The 5008X Machine is available equipped with a Crit-Line Clip (CLiC) Monitor System. The optional CLiC system is used to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

Caution: Federal (US) law restricts these devices to sale by or on the order of a physician. 

© 2026 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, the triangle logo, 5008X, bibag, Crit-Line, CLiC are trademarks for which Fresenius Medical Care AG holds rights. All other trademarks are the property of their respective owners. D/N US-HDF-000011 Rev A 04/2026

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