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

Cardiovascular Diseases Clinical Trial

— MoDal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03510520
• Other study ID #: R04863
• Status: Completed
• Phase: N/A
• Start date: September 14, 2018
• Est. completion date: May 9, 2019

Study information

• Verified date: August 2019
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 9, 2019
• Est. primary completion date: May 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• End Stage Renal Disease
• Inflammation
• Kidney Failure, Chronic

Intervention

Device:
• Medium Cut-Off Haemodialysis
Treatment with medium cut-off haemodialysis using the Theranova dialysis membrane 3 times per week for 6 months
• On-Line Haemodiafiltration
Treatment with on-line haemodiafiltration (HDF) 3 times per week for 6 months (Conventional treatment)

Locations

Country	Name	City	State
United Kingdom	Manchester NHS Foundation Trust	Manchester	Lancashire

Sponsors (3)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust	Baxter Healthcare Corporation, Manchester Metropolitan University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in endothelial function (composite of endothelial microvesicle levels, pro-inflammatory & pro-coagulant markers)	Change in vascular endothelial marker score (derived from multiple biomarkers)	6 months
Secondary	Change in pulse wave velocity	Change in pulse wave velocity as measured by non-invasive pulse wave analysis device	6 months
Secondary	Change in pre-dialysis serum albumin	Change in pre-dialysis serum albumin	3 & 6 months
Secondary	Change in pre-dialysis CRP	Change in pre-dialysis CRP	3 & 6 months
Secondary	Change in components of pre-dialysis "middle molecule" panel	Change in components of pre-dialysis "middle molecule" panel (this includes beta 2 microglobulin, serum free light chains, leptin, beta trace protein and prolactin)	3 & 6 months
Secondary	Change in components of cytokine panel	Change in components of cytokine panel (including IL-6, TNFa, ICAM & VEGF)	3 & 6 months
Secondary	Change in numbers blood pressure medications	Change in numbers blood pressure medications	6 months
Secondary	Change in number of phosphate binder medications	Change in number of phosphate binder medications	6 months
Secondary	Change in Advanced Glycation End Products (AGE)	Change in Advanced Glycation End Products (AGE)	6 months
Secondary	Change in inter-dialytic urine volume	Change in inter-dialytic urine volume	6 months
Secondary	Change in IPOS-Renal (Integrated Palliative Care Outcome Score)	Change in IPOS-Renal (Integrated Palliative Care Outcome Score)	3 & 6 months
Secondary	Change in self-sported dialysis recovery time	Change in self-sported dialysis recovery time	3 & 6 months
Secondary	Change in Chalder fatigue scale	Change in Chalder fatigue scale (score range 0 to 33, high score indicating high levels of fatigue)	3 & 6 months
Secondary	Hospitalisation episodes	Number of hospitalisation episodes during 6 months study period	6 months
Secondary	All-cause mortality	All-cause mortality	6 months
Secondary	Cardiovascular mortality	Cardiovascular mortality	6 months
Secondary	Change in augmentation pressure (AP)	Change in segmentation pressure as measured by non-invasive pulse wave analysis device	6 months
Secondary	Change in heart-rate adjusted augmentation index (AI)	Change in heart-rate adjusted augmentation index (AI) as measured by non-invasive pulse wave analysis device	6 months