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Trial record 1 of 1 for:    NCT03510520
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Comparison of MCO HD on Markers of Vascular Health Compared With On-Line Haemodiafiltration (MoDal)

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ClinicalTrials.gov Identifier: NCT03510520
Recruitment Status : Completed
First Posted : April 27, 2018
Last Update Posted : August 9, 2019
Sponsor:
Collaborators:
Manchester Metropolitan University
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
End Stage Renal Disease Cardiovascular Diseases Inflammation Device: Medium Cut-Off Haemodialysis Device: On-Line Haemodiafiltration Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a single-centre, pilot, open-label, interventional, randomised controlled study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Study Investigating the Effect of Medium Cut-Off Haemodialysis On Markers of Vascular Health Compared With On-Line HDF
Actual Study Start Date : September 14, 2018
Actual Primary Completion Date : May 9, 2019
Actual Study Completion Date : May 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Medium Cut-Off Haemodialysis (Theranova)
Participants will receive medium cut-off haemodialysis treatment for 6 months in total (3 times per week treatment).
Device: Medium Cut-Off Haemodialysis
Treatment with medium cut-off haemodialysis using the Theranova dialysis membrane 3 times per week for 6 months

Active Comparator: On-Line Haemodiafiltration
Participant will remain on their usual on-line haemodiafiltration (HDF) treatment for the 6 month study duration (3 times per week treatment).
Device: On-Line Haemodiafiltration
Treatment with on-line haemodiafiltration (HDF) 3 times per week for 6 months (Conventional treatment)




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03510520


Locations
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United Kingdom
Manchester NHS Foundation Trust
Manchester, Lancashire, United Kingdom, M13 9WL
Sponsors and Collaborators
Manchester University NHS Foundation Trust
Manchester Metropolitan University
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Sandip Mitra, MBBS Manchester University NHS Foundation Trust
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Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03510520    
Other Study ID Numbers: R04863
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This is yet to be determined

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manchester University NHS Foundation Trust:
Hemodialysis
Haemodialysis
Hemodiafiltration
Haemodiafiltration
Dialysis membrane
Endothelial Microvesicles
Pulse Wave Velocity
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Cardiovascular Diseases
Inflammation
Pathologic Processes
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency