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
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|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a single-centre, pilot, open-label, interventional, randomised controlled study.|
|Masking:||None (Open Label)|
|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|
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)
- 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)
- 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
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
|Manchester NHS Foundation Trust|
|Manchester, Lancashire, United Kingdom, M13 9WL|
|Principal Investigator:||Sandip Mitra, MBBS||Manchester University NHS Foundation Trust|