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Completed

NCT Number: NCT03510520

Comparison of MCO HD on Markers of Vascular Health Compared With On-Line Haemodiafiltration

The aim of this study is to evaluate haemodialysis treatment using a medium cut-off dialysis membrane (Theranova) compared with on-line haemodiafiltration treatment with respect to markers of endothelial health (plasma endothelial microvesicle levels, pro-inflammatory and pro-coagulant markers).

This study will also compare the 2 treatment modalities with respect to several other outcome measures including patient-reported outcome measures, haemodynamic parameters and advanced glycation end-products.

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Key information

Conditions

End Stage Renal Disease Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Inflammation Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manchester NHS Foundation Trust

Manchester, Lancashire, M13 9WL, United Kingdom

About this study

To date, methods of improving outcomes for haemodialysis patients have focused on improving small molecule clearance (urea); however, the benefits do not appear to be linear and increasing Kt/V above 1.3 shows no benefit. Current dialysis therapies are unable to provide effective clearance of larger "middle molecules" (between 20kDa and 60kDa) and retention of these molecules may be linked to poor outcomes in haemodialysis patients.

Medium cut-off (MCO) dialysis membranes have been recently developed to address this area of unmet need and provide an enhanced clearance of some larger middle molecules when compared with high flux haemodialysis (HFHD) and even high volume haemodiafiltration (HDF). The clinical benefit of this therapy is yet to be defined.

The aim of this study is to investigate the effect of HDx therapy (expanded haemodialysis therapy through the use of a MCO haemodialysis membrane- Theranova) on vascular endothelial and inflammatory biomarkers compared with high volume HDF therapy. Through the use of endothelial microvesicles (EMV) as a marker of vascular endothelial health, which strongly correlate with cardiovascular outcomes in end-stage real disease (ESRD) patients, this pilot study will take the first steps into exploring whether HDx treatment provides clinical benefits in addition to its simplicity of implementation. Additionally, other important parameters, such as dialysis recovery time, patient-reported outcome measures and volume management will also be explored and compared with high volume HDF.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Established on in-centre haemodiafiltration (HDF) for greater than 12 weeks with a minimum of 3 treatment sessions per week
  • Ability to consent

Exclusion criteria

  • Planned live donor renal transplant within 6 months (with confirmed date)
  • Planned switch in renal replacement modality (ie. to peritoneal dialysis or home haemodialysis)
  • Clinician predicted prognosis < 6 months

Treatment and study plan

Medium Cut-Off Haemodialysis

Device

Treatment with medium cut-off haemodialysis using the Theranova dialysis membrane 3 times per week for 6 months

On-Line Haemodiafiltration

Device

Treatment with on-line haemodiafiltration (HDF) 3 times per week for 6 months (Conventional treatment)

Primary outcomes

  1. Change in endothelial function (composite of endothelial microvesicle levels, pro-inflammatory & pro-coagulant markers)

    Time frame: 6 months

    Change in vascular endothelial marker score (derived from multiple biomarkers)

Secondary outcomes

  1. Change in pulse wave velocity

    Time frame: 6 months

    Change in pulse wave velocity as measured by non-invasive pulse wave analysis device

  2. Change in pre-dialysis serum albumin

    Time frame: 3 & 6 months

    Change in pre-dialysis serum albumin

  3. Change in pre-dialysis CRP

    Time frame: 3 & 6 months

    Change in pre-dialysis CRP

  4. Change in components of pre-dialysis "middle molecule" panel

    Time frame: 3 & 6 months

    Change in components of pre-dialysis "middle molecule" panel (this includes beta 2 microglobulin, serum free light chains, leptin, beta trace protein and prolactin)

  5. Change in components of cytokine panel

    Time frame: 3 & 6 months

    Change in components of cytokine panel (including IL-6, TNFa, ICAM & VEGF)

  6. Change in numbers blood pressure medications

    Time frame: 6 months

    Change in numbers blood pressure medications

  7. Change in number of phosphate binder medications

    Time frame: 6 months

    Change in number of phosphate binder medications

  8. Change in Advanced Glycation End Products (AGE)

    Time frame: 6 months

    Change in Advanced Glycation End Products (AGE)

  9. Change in inter-dialytic urine volume

    Time frame: 6 months

    Change in inter-dialytic urine volume

  10. Change in IPOS-Renal (Integrated Palliative Care Outcome Score)

    Time frame: 3 & 6 months

    Change in IPOS-Renal (Integrated Palliative Care Outcome Score)

  11. Change in self-sported dialysis recovery time

    Time frame: 3 & 6 months

    Change in self-sported dialysis recovery time

  12. Change in Chalder fatigue scale

    Time frame: 3 & 6 months

    Change in Chalder fatigue scale (score range 0 to 33, high score indicating high levels of fatigue)

  13. Hospitalisation episodes

    Time frame: 6 months

    Number of hospitalisation episodes during 6 months study period

  14. All-cause mortality

    Time frame: 6 months

    All-cause mortality

  15. Cardiovascular mortality

    Time frame: 6 months

    Cardiovascular mortality

  16. Change in augmentation pressure (AP)

    Time frame: 6 months

    Change in segmentation pressure as measured by non-invasive pulse wave analysis device

  17. Change in heart-rate adjusted augmentation index (AI)

    Time frame: 6 months

    Change in heart-rate adjusted augmentation index (AI) as measured by non-invasive pulse wave analysis device

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Collaborators

  • Baxter Healthcare Corporation
  • Manchester Metropolitan University

Registry information

Official study title

A Randomised Study Investigating the Effect of Medium Cut-Off Haemodialysis On Markers of Vascular Health Compared With On-Line HDF

Acronym: MoDal

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 27, 2018
Registry last updated
Aug 9, 2019

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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