HDx therapy

Treatment effects and therapy implications with the THERANOVA dialyzer

In two clinical studies, comparing the THERANOVA dialyzer with the latest generation high-flux dialyzer, the THERANOVA dialyzer demonstrated enhanced purification across a wide range of large middle molecules.1,2

Overall clearance

Reduction ratio

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PerCom Trials

Click the following link to read the full PerCom trial report published in the NDT Journal

The Nephrology Dialysis Transplantation (NDT) Journal gives you the opportunity to take a closer look at the PerCom study results and discover the clinical benefits of an HDx therapy option for your chronic HD patients.

  • Two clinical studies comparing the THERANOVA dialyzer with latest generation high-flux dialyzers
  • Enhanced blood purification of wide range of large middle molecule.
  • Greater clearances and intradialytic reduction ratios than regular HD - at ordinary blood flow rates
  • Similar to greater removal in comparison to high-volume HDF
  • Albumin removal limited to between 1 and 4 grams
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Additional resources

Want to read more about HDx therapy achieved through membrane innovation? Download the resources below to get more information.

ABSTRACT #SP481, ERA-EDTA 2018

A mid-term report of HD treatments with the new dialyzers with medium cut-off membrane (MCO Theranova)

Data from a 6 months observational study in 14 patients showing reduced pre-dialysis levels of several uremic toxins, including b2-microglobulin and kappa and lambda free light chains.

Reference: ERA-EDTA 2018 Abstract SP481 Nephrol Dial Transplant 2018; 33 (Suppl. 1)i510

ABSTRACT

V. CANTALUPPI ET AL

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Abstract #SP489, ERA-EDTA 2018

Mid-term evaluation of the new medium cut-off filter (Theranova) on removal efficiency and quality of life

Data from a 2 months observational study in 14 patients showing effective removal of middle molecules with no impact on pre-dialysis levels. Patient-reported SF-36 data showed a tendency for increase in the Physical Health index. Reductions in CRP level and Erythropoiesis resistance index was also found, although statistically non-significant.

Reference: ERA-EDTA 2018 Abstract SP489 Nephrol Dial Transplant 2018; 33 (Suppl. 1)i513

ABSTRACT

G. GERNONE ET AL

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Abstract #FP458, ERA-EDTA 2018

Comparison of high-flux hemodialyzers with medium cut-off dialyzer on the removal of middle high size uremic toxins

Reduction ratios evaluated for beta2m, myoglobin, kappa LC, and lambda LC. Theranova and Phylter UP showing similar reduction ratios for all solutes, incl. lambda FLC. Albumin removal greater with Phylter UP (average 4.1 gram) than for Theranova (average 1.9 g)

Reference: ERA-EDTA 2018 Abstract SP458 Nephrol Dial Transplant 2018; 33 (Suppl. 1)i190

ABSTRACT

S. BOVE ET AL

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Abstract #FP453, ERA-EDTA 2018

Expanded hemodialysis vs online hemodiafiltration for middle sized molecules clearance

Single treatment cross-over study in 8 patients on pre- vs post treatment levels of biomarkers for HDx with Theranova 500 in comparison to HDF. Results were similar reductions in plasma level for urea and beta-2-microglobulin, while the larger uremic toxins myoglobin and prolactin showed greater reduction with expanded hemodialysis.

Reference: ERA-EDTA 2018 Abstract SP453 Nephrol Dial Transplant 2018; 33 (Suppl. 1)i190

ABSTRACT

J. REQUE ET AL

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Abstract #SP468, ERA-EDTA 2018

Effects on clinical and dialytic parameters with a new medium cut off membrane dialyzer in conventional hemodialysis compared to a high flux dialyzer in online hemodiafiltration

Eight patients in 2 week observational study after conversion from HDF (N=7) or HD (N=1) to HDx. No incidents or clinical side effects; Kt/V unchanged; no change in regular clinical markers except for increase in hemoglobin and lower PTH level in comparison to baseline levels.

Reference: ERA-EDTA 2018 Abstract SP468 Nephrol Dial Transplant 2018; 33 (Suppl. 1)i505

ABSTRACT

F. HADAD ET AL

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Abstract #FP466, ERA-EDTA 2018

New medium cut-off membrane vs hemodiafiltration in clearance of middle molecules. Preliminary results from our centre

Myoglobin reduction ratio assessed in 4 patients shifted from conventional HD to HDx therapy and compared to 4 other patients maintained on on-line HDF. Significantly greater reduction ratio with HDx, not different to the reduction ratio in HDF.

Reference: ERA-EDTA 2018 Abstract SP466 Nephrol Dial Transplant 2018; 33 (Suppl. 1)i193

ABSTRACT

P. ALBRIZIO ET AL

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Abstract #FP444, ERA-EDTA 2018

Plasma molecular changes in hemodialysis patients with polyarylethersulfone-polyvinylpyrrolidone membrane dialyzer (Theranova 400 Baxter)

Single treatment cross-over study on pre- vs post treatment levels of biomarkers for Theranova 400 in comparison to standard polysulfone high-flux dialyzer in 8 patients. Conclusion is that Theranova treatment shows greater percentage reduction of the middle molecules myoglobin, procalcitonin and beta2-microglobulin.

Reference: ERA-EDTA 2018 Abstract SP444 Nephrol Dial Transplant 2018; 33 (Suppl. 1)i184

ABSTRACT

L. CELIK

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ARTICLE

Hypoalbuminemia: a price worth paying for improved dialytic removal of middle-molecular-weight uremic toxins?

Reference: DOI: 10.1093/ndt/gfy236

ARTICLE

R. WARD ET AL

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ARTICLE

Evaluation of the efficacy of a medium cut-off dialyser and comparison with other high-flux dialysers in conventional haemodialysis and online haemodiafiltration

Reference: DOI: 10.1093/ckj/sfy004

ARTICLE

A. GARCIA-PRIETO ET AL

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ARTICLE

Exploring the Clinical Relevance of Providing Increased Removal of Large Middle Molecules

Reference: DOI: 10.2215/​CJN.10110917

ARTICLE

M. WOLLEY ET AL

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ARTICLE

Haemodialysis membranes

Reference: Nature Reviews Nephrologyvolume 14, pages394–410 (2018)

ARTICLE

C. RONCO & WR. CLARK

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ARTICLE, 2018

Assessment of the association between increasing membrane pore size and endotoxin permeability using a novel experimental dialysis simulation set-up

A realistic in vitro dialysis was developed to assess membrane translocation of bacterial products. LAL activity on the blood side after endotoxin exposure did not change for all membranes. Also, none of the PVPpost solutions induced IL-1β in the THP-1 bio-assay.

Reference: DOI 10.1186/s12882-017-0808-y

Article

E. SCHEPERS ET AL.

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ARTICLE, 2017

Expanded Hemodialysis Innovative Clinical Approach in Dialysis

This book contains emerging evidence and fascinating new hypotheses on HDx. It is highly recommended for all physicians and healthcare professionals who are caring for dialysis patients and are seeking innovation and improved care solutions. The material is available on-line for free by downloading the individual chapters (available in PDF format).

Reference: DOI: 10.1159/000479262

Article

C. RONCO ET AL.

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ARTICLE, 2017

Comparison of hemodialysis with medium cut-off dialyzer and on-line hemodiafiltration on the removal of small and middle-sized molecules.

This study shows that the use of MCO (Theranova) dialyzer in HD produces similar removal of urea, creatinine, β2-microglobulin and myoglobin as does ol-HDF, with good tolerance profile and without modification of nutritional status

Reference: Clin Nephrol. 2017 Aug 30. doi: 10.5414/CN109133.

ARTICLE

M. BELMOUAZ ET AL.

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ARTICLE, 2017

The Rise of Expanded Hemodialysis

This article is describing the rise of a new concept therapy called "expanded hemodialysis" - "This new therapy is likely to modify the outcome of endstage kidney disease patients, thanks to the enhanced removal of molecules traditionally retained by current dialysis techniques."

Reference: Blood Purif 2017;44:I-VIII

Article

Ronco C.

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ARTICLE, 2017

Medium cut-off membranes - closer to the natural kidney removal function

A comprehensive editorial on novel MCO membranes for expanded hemodialysis to remove large middle molecules that are less effectively removed with conventional membranes

Reference: DOI:10.5301/ijao.5000603

Article

C. ZWEIGART, A. BOSCHETTI-DE-FIERRO, M. HULKO, et al

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ABSTRACT #SA-PO760, ASN 2017

Clinical Experiences of a New Expanded Hemodialysis Therapy with a Novel Medium Cut-Off Dialyzer

HDx therapy was convenient, simple to implement, and achieved high β2M RRs with low albumin loss. It offers opportunity for achieving the clearance of middle molecules delivered by HDF, when patient factors exist or HDF is not available. Based on 2 of 4 HDF patients and all 14 HDx patients.

Reference: J Am Soc Nephrol 28: 2017

Abstract .PDF/139 KB

J. BAHARANI ET AL

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Abstract #P33, ESAO 2017

Sieving coefficients of hemodialysis membranes

This study shows that care must be taken when SC of dialyzers are compared when the intended use is only partly the same but not identical. This study thus offers SC obtained under identical conditions.

Reference: DOI: 10.5301/ijao.5000641

Abstract

M. HULKO ET AL

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Abstract #SP488, ERA-EDTA 2017

Retention of different types of pyrogens by membranes of different pore size

In this study dialyzer membranes of different pore sizes were tested for their capacity to prevent pyrogens crossing from dialysate to blood side and differentiating between PG, LPS, and bDNA.

Reference: ERA-EDTA 2017 Abstract SP488 Nephrol Dial Transplant 2017;32 (Suppl 3)iii291-292

Abstract

M. HULKO ET AL

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ABSTRACT #SA-PO761, ASN 2017

Comparison of Albumin Binding Capacity and Uremic Toxins in Hemodiafiltration versus Novel Dialysis Membrane

Expanded hemodialysis enabled by Theranova demonstrates equal effects on ABIC and uremic toxins in comparison to OL-HDF.

Reference: J Am Soc Nephrol 28: 2017

Abstract .PDF/134 KB

S.KOBALL ET AL.

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Abstract #MP537, ERA-EDTA 2017

Does increasing membrane pore size affect endotoxin permeability? A novel dialysis simulation set-up

In the present study a realistic dialysis set-up was developed and therewith permeability for bacterial degradation products of 4 commercial dialyzers of comparable composition but with increasing pore size was tested.

Reference: ERA-ETA 2017 Abstract MP537 Nephrol Dial Transplant 2017; 32 (Suppl 3)iii625-626

Abstract

E. SCHEPERS ET AL

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Abstract #MP527, ERA-EDTA 2017

Removal evaluation of a new dialyzer with medium cut-off membrane in HD treatments

This study was addressed to evaluate the removal efficacy of Theranova® in standard HD by the Reduction Rate (RR) in comparison with our data achieved with three different types of online postdilution HDF treatments

Reference: ERA-EDTA 2017 Abstract MP527 Nephrol Dial Transplant 2017; 32 (Suppl 3)iii622-623

Abstract

U. TEATINI ET AL

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Abstract #MP538,ERA-EDTA 2017

A short-term report of HD treatments with the new Theranova dialyzers

In this study the removal efficacy of THERANOVA in standard HD in a case study was evaluated.

Reference: ERA-EDTA 2017 Abstract MP538 Nephrol Dial Transplant 2017; 32 (Suppl 3):iii625-626

Abstract

U. TEATINI ET AL

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POSTER # FP478, ERA-EDTA 2015

MCO (Medium Cut-Off Membranes: Enhanced Selectivity in High-Flux Class)

A comprehensive in vitro characterization of THERANOVA dialyzer's novel MCO high-flux membrane for hemodialysis, showing permeability close to that of the natural kidney.

Reference: ERA-EDTA 2015 Abstract FP478 Nephrol Dial Transplant 2015;30 (Suppl 3):iii231

Poster .PDF / 225 KB

A. Boschetti De Dierro, M. Voigt, M. Storr, B. Krause

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Poster #SAT-481, WCN 2015

MCO Dialyzers:
Enhanced Selectivity High-Flux

Using in vitro data, a study assess the effectiveness of MCO dialyzers in simulated hemodialysis (HD) and hemodiafiltration (HDF) treatments.

Reference: WCN 2015 Abstract SAT-481

Poster .PDF / 74 KB

A. Boschetti de Fierro, M. Voigt, M. Hulko, M. Storr, B. Krause

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Poster #FP504, ERA-EDTA 2015

Hemoglobin removal by dialyzers of different permeability profiles

A study measuring cell-free plasma hemoglobin clearance of conventional high-flux dialysis filters, high-flux filters with extended permeability and high cut-off dialyzers.

Reference: ERA-EDTA 2015 Abstract FP504 Nephrol Dial Transplant 2015;30(Suppl 3):iii240

Poster .PDF / 98 KB

M. HULKO, M. EBBERS, M. YILDIRIM, S. HOMEYER, B. KRAUSE

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Poster #FP516, ERA-EDTA 2015

Dialysis membrane pore size does not determine LPS retention

A study to challenge the belief that dialysis membranes having larger pore sizes are less effective in retaining LPS in dialysis fluid than low-flux, high-flux and high flux membrane of the same material and structure.

Reference: ERA-EDTA 2015 Abstract FP516 Nephrol Dial Transplant 2015;30(Suppl 1):iii244

Poster .PDF / 90 KB

M. HULKO, A. GEKELER, I. KOCH, V. DIETRICH, B. KRAUSE

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Poster #SP426, ERA-EDTA 2015

Changes in coagulation factors and inhibitors during simulated HD with the novel medium cut-off high flux membrane

An investigation across a set of coagulation factors and inhibitors (molecular weight 50 to 71.6 kDa) during in-vitro dialysis with highly permeable dialysis membranes.

Reference: ERA-EDTA 2016 Abstract SP426 Nephrol Dial Transplant 2016;31(Suppl 3):i233

Poster .PDF / 242 KB

M. HULKO, A. GEKELER, I. KOCH, V. DIETRICH, B. KRAUSE

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WEBINAR

Expanded Hemodialysis - A step closer to natural kidneys

Dr. Claudio Ronco was joined by a faculty of distinguished nephrologists, including Ziad Massy from Paris, France and Peter Stenvinkel from Stockholm, Sweden for a symposium that gave attendees a state-of-the-art update on the toxicity of uremic solutes, with a focus on large middle molecules.

WEBINAR

EXPANDED HEMODIALYSIS: A STEP CLOSER TO NATURAL KIDNEY

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