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Completed

NCT Number: NCT03448887

Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration

Theranova is a novel medium cut-off (MCO) dialyzer. Previous studies identified that theranova dialyzer had superior performance on middle molecule removal to conventional hemodialysis (HD) and hemodiafiltration (HDF). The present study addresses to compare clinical outcomes including cardiovascular endpoint between HD with theranova dialyzer and HDF.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital, Gyeonggi-do, South Korea

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About this study

While conventional hemodialysis (HD) modality effectively removes small-sized molecules, performance with middle-sized and protein-bound molecules is not well established. With increasing perception on importance of middle molecule removal, on-line hemodiafiltration (HDF) is getting more attention from healthcare professionals. However, HDF has not been widely used in Korea due to its technical burden and limited public funding issue.

Novel medium cut-off (MCO) dialyzer, Theranova, is available in Korea, which showed superior performance on middle molecule removal to conventional HD and HDF from the previous study. This new dialyzer can be a good alternative option replacing conventional HD or even HDF with its benefits. However, current data available on the MCP dialyzer has certain limitations such as small sample size, no Asian subject included, limited types of biomarkers, and no clinical outcomes (particularly cardiovascular diseases) included.

With this respect, performance comparison of MCO dialyzer with HDF in terms of clinical outcomes, including cardiovascular endpoint would fill the exiting data gap, which is absolutely important to make a clinical decision on dialysis modality.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old and older
  • Hemodialysis more than 3 months because of end-stage renal disease
  • Consent to the study protocol

Exclusion criteria

  • Already receiving online hemodiafiltration before study enrollment
  • Dialysis schedule other than three times per week (e.g., once per week)
  • Receiving concurrent peritoneal dialysis
  • Having a plan to receive kidney transplantation within 1 year
  • Having multiple myeloma or monoclonal gammopathy
  • Having advanced or active malignancy
  • Having a plan to be pregnant or being pregnant / breast-feeding or not having a plan to use contraception
  • Participating in other clinical trials

Treatment and study plan

Theranova

Device

Extended HD with theranova

Online Hemodiafiltration

Device

Online hemodiafiltration

Primary outcomes

  1. Change in cardiovascular surrogate marker

    Time frame: 0, 6, 12 months

    Brachial-ankle pulse wave velocity (m/s)

Secondary outcomes

  1. Change in cardiac surrogate marker #1

    Time frame: 0, 6, 12 months

    CT coronary calcium scoring (score)

  2. Change in cardiac surrogate marker #2

    Time frame: 0, 6, 12 months

    Echocardiography: ejection fraction (%); E/e' ratio (cm/s per cm/s); LVMI (g/m2).

  3. Change in cardiovascular biomarkers #1

    Time frame: 0, 6, 12 months

    Plasma levels of BNP (pg/ml)

  4. Change in cardiovascular biomarkers #2

    Time frame: 0, 6, 12 months

    Plasma levels of NT-proBNP (pg/ml)

  5. Change in cardiovascular biomarkers #3

    Time frame: 0, 6, 12 months

    Plasma levels of hsCRP (mg/dl)

  6. Change in cardiovascular biomarkers #4

    Time frame: 0, 6, 12 months

    Plasma levels of troponin-I (ng/ml)

  7. Change in cardiovascular biomarkers #5

    Time frame: 0, 6, 12 months

    Plasma levels of troponin-T (ng/ml)

  8. Change in cardiovascular biomarkers #6

    Time frame: 0, 6, 12 months

    Plasma levels of IL-6 (pg/ml)

  9. Patient-reported outcomes #1

    Time frame: 0, 6, 12 months

    Dialysis symptom index (score)

  10. Patient-reported outcomes #2

    Time frame: 0, 6, 12 months

    Degree of fatigue after dialysis (scale from 0 to 10)

  11. Patient-reported outcomes #3

    Time frame: 0, 6, 12 months

    Post-dialysis recovery time (within minutes, when arriving home, at bed time, next morning, by next dialysis)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Baxter Healthcare Corporation
  • Samsung Medical Center
  • Seoul National University Bundang Hospital
  • Seoul St. Mary's Hospital

Registry information

Official study title

Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration - Exploratory, Multicenter, Randomized Clinical Trial

Acronym: CARTOON

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 28, 2018
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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