Evidence map›Paper›PMID 32843372›Full record

Trial reportClinical journal of the American Society of Nephrology : CJASN2020

Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 Dialyzer: A Randomized Controlled Trial.

Daniel E Weiner, Luke Falzon, Line Skoufos, Angelito Bernardo, Werner Beck, Mengqi Xiao, Ha Tran

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical journal of the American Society of Nephrology : CJASN, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03257410 (A Multi-Center, Prospective, Randomized, Controlled, Open-label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer In End Stage Renal Disease), which is not on this map. Cited by 45 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 3 pooled it
7.3field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03257410 nacompletednot on this map

A Multi-Center, Prospective, Randomized, Controlled, Open-label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients

TypeinterventionalSponsorVantive Health LLCRan2017 to 2018Enrolled172ConditionsEnd Stage Renal DiseaseArmsTheranova 400 dialyzer, Elisio-17H dialyzer
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 3 syntheses or guidelines pooled it, 76 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Efficacy of medium cut-off dialyzers and comparison with high-flux dialyzers in patients on maintenance hemodialysis: A systematic review and meta-analysis.Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy · 2022
    Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Increasing the Removal of Large Solutes by Kidney Replacement Therapy.Journal of the American Society of Nephrology : JASN · 2025
    Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Twice Weekly versus Thrice Weekly Hemodialysis-A Pilot Cross-Over Equivalence Trial.Clinical journal of the American Society of Nephrology : CJASN · 2024
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

Daniel E WeinerTufts Medical Center, Medicine, Nephrology, Boston, Massachusetts.
Luke FalzonBaxter Healthcare Corporation, Worldwide Medical, San Gwann, Malta.
Line SkoufosBaxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.
Angelito BernardoBaxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.
Werner BeckBaxter International Inc., Worldwide Medical, Hechingen, Germany.
Mengqi XiaoBaxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.
Ha TranBaxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.
Baxter (United States) · USBaxter (Germany) · DETufts Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesExpanded hemodialysis therapy enabled by medium cut-off membranes may promote greater clearance of larger middle molecules that comprise putative uremic solutes than conventional high-flux dialysis. This randomized trial evaluated the efficacy and safety of hemodialysis treatment with a medium cut-off dialyzer. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Clinically stable patients on maintenance hemodialysis were randomized to receive dialysis with either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (Elisio-17H) over 24 weeks of treatment. The primary safety end point was the predialysis serum albumin level after 24 weeks of treatment. The primary efficacy end point was the reduction ratio of free

resultsAmong 172 patients on maintenance hemodialysis, mean age was 59±13 years, 61% were men, 40% were Black, and mean dialysis vintage was 5±4 years. Of the 86 patients randomized to each dialyzer, 65 completed the trial in each group. The reduction ratio for the removal of free

conclusionsHemodialysis therapy with the Theranova 400 dialyzer provides superior removal of larger middle molecules, as exemplified by free CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: A Multi-Center, Prospective, Randomized, Controlled, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer in End Stage Renal Disease (ESRD) Patients, NCT03257410.

Indexed as

Membranes, ArtificialAgedbeta 2-MicroglobulinBiomarkersEquipment DesignFemaleHumansImmunoglobulin kappa-ChainsImmunoglobulin lambda-ChainsKidney DiseasesMaleMiddle AgedRenal DialysisSerum Albumin, HumanTime FactorsTreatment OutcomeALB protein, humanB2M protein, humanbeta 2-MicroglobulinBiomarkersImmunoglobulin kappa-ChainsImmunoglobulin lambda-ChainsMembranes, ArtificialSerum Albumin, HumanTNF protein, humanTumor Necrosis Factor-alphachronic dialysischronic inflammationdialysisend-stage kidney diseaseESKDhemodialysismaintenance dialysisrandomized controlled trialsrenal dialysis

Identifiers

PMID32843372
PMCPMC7480550
OpenAlexW3080840376

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.