End Stage Renal DiseaseMoDalNCT03510520
Comparison of MCO HD on Markers of Vascular Health Compared With On-Line Haemodiafiltration
A study testing Medium Cut-Off Haemodialysis and On-Line Haemodiafiltration in people with End Stage Renal Disease and Cardiovascular Diseases, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Cardiovascular Diseases, Inflammation
- What is being tested?
- Medium Cut-Off Haemodialysis and On-Line Haemodiafiltration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Sep 2018to 9 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established on in-centre haemodiafiltration (HDF) for greater than 12 weeks with a minimum of 3 treatment sessions per week
- Ability to consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester NHS Foundation Trust
Manchester, Lancashire, M13 9WL
About this study
Official title: A Randomised Study Investigating the Effect of Medium Cut-Off Haemodialysis On Markers of Vascular Health Compared With On-Line HDF
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.
Read the 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.
- Being tested
- Medium Cut-Off Haemodialysis, On-Line Haemodiafiltration
- Keywords
- Hemodialysis, Haemodialysis, Hemodiafiltration, Haemodiafiltration, Dialysis membrane, Endothelial Microvesicles, Pulse Wave Velocity
- Medical subject headings
- Kidney Failure, Chronic, Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium Cut-Off HaemodialysisDevice
Treatment with medium cut-off haemodialysis using the Theranova dialysis membrane 3 times per week for 6 months
On-Line HaemodiafiltrationDevice
Treatment with on-line haemodiafiltration (HDF) 3 times per week for 6 months (Conventional treatment)
| Study group | Role | What they receive |
|---|---|---|
| Medium Cut-Off Haemodialysis (Theranova) | Experimental | Participants will receive medium cut-off haemodialysis treatment for 6 months in total (3 times per week treatment). Receives: Device: Medium Cut-Off Haemodialysis |
| On-Line Haemodiafiltration | Active comparator | Participant will remain on their usual on-line haemodiafiltration (HDF) treatment for the 6 month study duration (3 times per week treatment). Receives: Device: On-Line Haemodiafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endothelial function (composite of endothelial microvesicle levels, pro-inflammatory & pro-coagulant markers)
Change in vascular endothelial marker score (derived from multiple biomarkers)
Measured: 6 months
Secondary outcomes (17)
Change in pulse wave velocity
Change in pulse wave velocity as measured by non-invasive pulse wave analysis device
Measured: 6 months
Change in pre-dialysis serum albumin
Change in pre-dialysis serum albumin
Measured: 3 & 6 months
Change in pre-dialysis CRP
Change in pre-dialysis CRP
Measured: 3 & 6 months
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)
Measured: 3 & 6 months
Change in components of cytokine panel
Change in components of cytokine panel (including IL-6, TNFa, ICAM \& VEGF)
Measured: 3 & 6 months
Change in numbers blood pressure medications
Change in numbers blood pressure medications
Measured: 6 months
Change in number of phosphate binder medications
Change in number of phosphate binder medications
Measured: 6 months
Change in Advanced Glycation End Products (AGE)
Change in Advanced Glycation End Products (AGE)
Measured: 6 months
Change in inter-dialytic urine volume
Change in inter-dialytic urine volume
Measured: 6 months
Change in IPOS-Renal (Integrated Palliative Care Outcome Score)
Change in IPOS-Renal (Integrated Palliative Care Outcome Score)
Measured: 3 & 6 months
Change in self-sported dialysis recovery time
Change in self-sported dialysis recovery time
Measured: 3 & 6 months
Change in Chalder fatigue scale
Change in Chalder fatigue scale (score range 0 to 33, high score indicating high levels of fatigue)
Measured: 3 & 6 months
Hospitalisation episodes
Number of hospitalisation episodes during 6 months study period
Measured: 6 months
All-cause mortality
All-cause mortality
Measured: 6 months
Cardiovascular mortality
Cardiovascular mortality
Measured: 6 months
Change in augmentation pressure (AP)
Change in segmentation pressure as measured by non-invasive pulse wave analysis device
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start14 Sep 2018
- Primary completion9 May 2019
- Study completion9 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-centre, pilot, open-label, interventional, randomised controlled study.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Manchester Metropolitan University, Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Sandip Mitra, MBBS, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510520
- Sponsor's protocol ID
- R04863
- Acronym
- MoDal
- Status last verified
- Aug 2019
- First submitted
- 12 Apr 2018
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is yet to be determined
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Study Investigating the Effect of Medium Cut-Off Haemodialysis On Markers of Vascular Health Compared With On-Line HDF
- ClinicalTrials.gov ID
- NCT03510520
- Acronym / sponsor ID
- MoDal / R04863
- Keywords
- Hemodialysis, Haemodialysis, Hemodiafiltration, Haemodiafiltration, Dialysis membrane, Endothelial Microvesicles, Pulse Wave Velocity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- Manchester Metropolitan University, Baxter Healthcare Corporation
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 9 May 2019 (actual)
- Study completion
- 9 May 2019 (actual)
- First posted
- 27 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-centre, pilot, open-label, interventional, randomised controlled study.
| Arm | Type | Receives |
|---|---|---|
| Medium Cut-Off Haemodialysis (Theranova) | Experimental | Device: Medium Cut-Off HaemodialysisParticipants will receive medium cut-off haemodialysis treatment for 6 months in total (3 times per week treatment). |
| On-Line Haemodiafiltration | Active comparator | Device: On-Line HaemodiafiltrationParticipant will remain on their usual on-line haemodiafiltration (HDF) treatment for the 6 month study duration (3 times per week treatment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Established on in-centre haemodiafiltration (HDF) for greater than 12 weeks with a minimum of 3 treatment sessions per week
- Ability to consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medium Cut-Off HaemodialysisTreatment with medium cut-off haemodialysis using the Theranova dialysis membrane 3 times per week for 6 months | Device | Medium Cut-Off Haemodialysis (Theranova) |
| On-Line HaemodiafiltrationTreatment with on-line haemodiafiltration (HDF) 3 times per week for 6 months (Conventional treatment) | Device | On-Line Haemodiafiltration |
Primary outcome
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)
17 secondary outcomes
Change in pulse wave velocity
Time frame: 6 months
Change in pre-dialysis serum albumin
Time frame: 3 & 6 months
Change in pre-dialysis CRP
Time frame: 3 & 6 months
Change in components of pre-dialysis "middle molecule" panel
Time frame: 3 & 6 months
Change in components of cytokine panel
Time frame: 3 & 6 months
Change in numbers blood pressure medications
Time frame: 6 months
Change in number of phosphate binder medications
Time frame: 6 months
Change in Advanced Glycation End Products (AGE)
Time frame: 6 months
Change in inter-dialytic urine volume
Time frame: 6 months
Change in IPOS-Renal (Integrated Palliative Care Outcome Score)
Time frame: 3 & 6 months
Change in self-sported dialysis recovery time
Time frame: 3 & 6 months
Change in Chalder fatigue scale
Time frame: 3 & 6 months
Hospitalisation episodes
Time frame: 6 months
All-cause mortality
Time frame: 6 months
Cardiovascular mortality
Time frame: 6 months
Change in augmentation pressure (AP)
Time frame: 6 months
Change in heart-rate adjusted augmentation index (AI)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Individual participant dataSharing planned: Undecided. This is yet to be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandip Mitra, MBBS principal investigator
Manchester University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medium Cut-Off Haemodialysis and On-Line Haemodiafiltration in people with End Stage Renal Disease and Cardiovascular Diseases, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endothelial function (composite of endothelial microvesicle levels, pro-inflammatory & pro-coagulant markers) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.