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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

Tracking Information
First Submitted Date  ICMJE April 12, 2018
First Posted Date  ICMJE April 27, 2018
Last Update Posted Date August 9, 2019
Actual Study Start Date  ICMJE September 14, 2018
Actual Primary Completion Date May 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
  • Change in pulse wave velocity [ Time Frame: 6 months ]
    Change in pulse wave velocity as measured by non-invasive pulse wave analysis device
  • Change in pre-dialysis serum albumin [ Time Frame: 3 & 6 months ]
    Change in pre-dialysis serum albumin
  • Change in pre-dialysis CRP [ Time Frame: 3 & 6 months ]
    Change in pre-dialysis CRP
  • 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)
  • Change in components of cytokine panel [ Time Frame: 3 & 6 months ]
    Change in components of cytokine panel (including IL-6, TNFa, ICAM & VEGF)
  • Change in numbers blood pressure medications [ Time Frame: 6 months ]
    Change in numbers blood pressure medications
  • Change in number of phosphate binder medications [ Time Frame: 6 months ]
    Change in number of phosphate binder medications
  • Change in Advanced Glycation End Products (AGE) [ Time Frame: 6 months ]
    Change in Advanced Glycation End Products (AGE)
  • Change in inter-dialytic urine volume [ Time Frame: 6 months ]
    Change in inter-dialytic urine volume
  • Change in IPOS-Renal (Integrated Palliative Care Outcome Score) [ Time Frame: 3 & 6 months ]
    Change in IPOS-Renal (Integrated Palliative Care Outcome Score)
  • Change in self-sported dialysis recovery time [ Time Frame: 3 & 6 months ]
    Change in self-sported dialysis recovery time
  • 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)
  • Hospitalisation episodes [ Time Frame: 6 months ]
    Number of hospitalisation episodes during 6 months study period
  • All-cause mortality [ Time Frame: 6 months ]
    All-cause mortality
  • Cardiovascular mortality [ Time Frame: 6 months ]
    Cardiovascular mortality
  • Change in augmentation pressure (AP) [ Time Frame: 6 months ]
    Change in segmentation pressure as measured by non-invasive pulse wave analysis device
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of MCO HD on Markers of Vascular Health Compared With On-Line Haemodiafiltration
Official Title  ICMJE A Randomised Study Investigating the Effect of Medium Cut-Off Haemodialysis On Markers of Vascular Health Compared With On-Line HDF
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • End Stage Renal Disease
  • Cardiovascular Diseases
  • Inflammation
Intervention  ICMJE
  • Device: Medium Cut-Off Haemodialysis
    Treatment with medium cut-off haemodialysis using the Theranova dialysis membrane 3 times per week for 6 months
  • Device: On-Line Haemodiafiltration
    Treatment with on-line haemodiafiltration (HDF) 3 times per week for 6 months (Conventional treatment)
Study Arms  ICMJE
  • Experimental: Medium Cut-Off Haemodialysis (Theranova)
    Participants will receive medium cut-off haemodialysis treatment for 6 months in total (3 times per week treatment).
    Intervention: Device: Medium Cut-Off Haemodialysis
  • 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).
    Intervention: Device: On-Line Haemodiafiltration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2019)
63
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2018)
64
Actual Study Completion Date  ICMJE May 9, 2019
Actual Primary Completion Date May 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03510520
Other Study ID Numbers  ICMJE R04863
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: This is yet to be determined
Responsible Party Manchester University NHS Foundation Trust
Study Sponsor  ICMJE Manchester University NHS Foundation Trust
Collaborators  ICMJE
  • Manchester Metropolitan University
  • Baxter Healthcare Corporation
Investigators  ICMJE
Principal Investigator: Sandip Mitra, MBBS Manchester University NHS Foundation Trust
PRS Account Manchester University NHS Foundation Trust
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP