NCT03510520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

September 14, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

April 12, 2018

Last Update Submit

August 8, 2019

Conditions

End Stage Renal DiseaseCardiovascular DiseasesInflammation

Keywords

HemodialysisHaemodialysisHemodiafiltrationHaemodiafiltrationDialysis membraneEndothelial MicrovesiclesPulse Wave Velocity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (17)

  • Change in pulse wave velocity

    6 months

  • Change in pre-dialysis serum albumin

    3 & 6 months

  • Change in pre-dialysis CRP

    3 & 6 months

  • Change in components of pre-dialysis "middle molecule" panel

    3 & 6 months

  • Change in components of cytokine panel

    3 & 6 months

  • +12 more secondary outcomes

Study Arms (2)

Medium Cut-Off Haemodialysis (Theranova)

EXPERIMENTAL

Participants will receive medium cut-off haemodialysis treatment for 6 months in total (3 times per week treatment).

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).

Device: On-Line Haemodiafiltration

Interventions

Medium Cut-Off HaemodialysisDEVICE

Treatment with medium cut-off haemodialysis using the Theranova dialysis membrane 3 times per week for 6 months

Medium Cut-Off Haemodialysis (Theranova)
On-Line HaemodiafiltrationDEVICE

Treatment with on-line haemodiafiltration (HDF) 3 times per week for 6 months (Conventional treatment)

On-Line Haemodiafiltration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Established on in-centre haemodiafiltration (HDF) for greater than 12 weeks with a minimum of 3 treatment sessions per week
  • Ability to consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manchester NHS Foundation Trust

Manchester, Lancashire, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Kidney Failure, ChronicCardiovascular DiseasesInflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sandip Mitra, MBBS

    Manchester University NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a single-centre, pilot, open-label, interventional, randomised controlled study.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2018

First Posted

April 27, 2018

Study Start

September 14, 2018

Primary Completion

May 9, 2019

Study Completion

May 9, 2019

Last Updated

August 9, 2019

Record last verified: 2019-08

Locations

GB(1)