Performance Evidence
HDx therapy enabled by Theranova dialyzer provides superior removal of large middle molecules compared with HD and HDF modalities and it can do so using regular HD workflow and infrastructure.1
Importance of Performance
Reduced levels of uremic solutes might indicate a reduced degree of uremic toxicity. Removal of uremic solutes can be evaluated by changes in levels over the course of a single treatment.
Primary clinical studies illuminate the benefits of HDx therapy enabled by Theranova dialyzer
Weiner DE et al. Efficacy and safety of expanded hemodialysis with the Theranova 400 dialyzer: A randomized controlled trial.
Theranova dialyzer provides significant and superior removal of conventional/large middle molecules compared to conventional hemodialysis while retaining stable albumin levels.2
Krishnasamy R et al. A trial evaluating mid out-off value membrane clearance of albumin and light chains in hemodialysis patients (REMOVAL-HD): a safety device study.
Theranova dialyzer efficiently removes middle molecules up to 45 kDa, such as lambda-FLC, while maintaining stable serum albumin levels, with only 0.7g/L decline in overall serum concentrations.3
Bunch A et al. Medium cut-off dialyzers in a large population of hemodialysis patients in Colombia: COREXH Registry.
Theranova dialyzer is safe and preserves serum albumin levels within the normal range among patients undergoing expanded hemodialysis.4
Kirsch AH et al. Performance of hemodialysis with novel medium cut-off dialyzers.
Theranova dialyzer provides efficient removal of large middle molecule uremic toxins compared to traditional high flux membranes used during high-flux hemodialysis and hemodiafiltration, with limited albumin between 1 and 4g per treatment.1
Belmouaz M et al. Comparison of Hemodialysis with Medium Cut-Off Dialyzer and On-Line Hemodiafiltration on the Removal of Small and Middle-Sized Molecules.
This study is the first evaluating efficacy and safety of MCO membrane with the new-generation Theranova-500 dialyzer in HD over a 6-month period, showing similar removal for small molecules, β-2 microglobulin and myoglobin when compared to ol-HDF, with good tolerance profile and without modification of nutritional status.5
Hagemann F et al. On the balance between albumin loss and removal of middle molecules in dialyzers.
Among four dialyzer membranes, the Theranova dialyzer offers the best compromise between good clearance of middle molecules and low albumin loss.6
Ronco C and Clark WR. Hemodialysis membranes.
Theranova dialyzer features an increased pore density with tight pore-size distribution, enhancing ultra-filtration and permeability via a steep sieving-curve — resulting in clearance of larger uremic toxins, while retaining essential proteins.7
Boschetti-de-Fierro A et al. MCO membranes: enhanced selectivity in high-flux class.
Tailored pore sizes of the Theranova dialyzer membranes promote removal of an expanded range of uremic toxins, while ensuring retention of albumin. The unique design of MCO membrane allows for a filtration profile that’s closer to the natural kidney.8
Lorenzin A et al. Flow Dynamic Analysis by Contrast-Enhanced Imaging Techniques of Medium Cutoff Membrane Hemodialyzer.
This study demonstrates the basis for the use of MCO membrane in expanded hemodialysis maximizing the benefits of internal filtration while maintaining the simplicity and safety of high-flux dialysis configuration and blood flows in the range of 300 mL/min.9
Reference library
Hear from patients, nephrologists, and nurses alike share their experience prescribing HDx therapy. Be reassured by the pioneering commitment of Baxter to dialysis patients the world over and learn how Theranova dialyzers are made.
HDx Therapy Evidence Compendium
On-going research and clinical reporting are an integral part of the HDx therapy journey. Explore the the expanding evidence related to HDx therapy enabled by Theranova dialyzer that nephrologists around the world continue to generate.
HDx Therapy Brochure
Here you can find the HDx therapy brochure with more information about prescribing HDx therapy for your hemodialysis patients.
HDx Therapy Specification Sheets
Here you can find the detailed profiles of Theranova dialyzers.
Important Safety Information
Theranova dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
*Do not use Theranova dialyzers in HDF or HF mode.
For safe and proper use of this device, please refer to Instructions for Use.
