NCT04106310

Brief Summary

This research proposal of an investigator-initiated clinical study aims to examine the impact of uremic toxin removal afforded by middle cut-off (MCO) dialysis on clinical parameters and surrogate biomarkers pertinent to nutritional, systemic and vascular complications in dialysis patients. The primary research goal is to evaluate the outcomes indicative of nutritional status (as measured by body mass index, body composition monitoring, albumin, clinical assessments such as subjective global assessment, etc.) and parameters relevant to pathophysiological processes in uremia focusing on inflammation and cardiovascular risks. The secondary research aims are to examine dialysis efficacy between MCO dialysis and conventional hemodialysis (CHD). Specifically, dialysis efficacy will be determined by within and between subject differences in baseline versus short term (6 months) and long term (12 months) effects of MCO dialysis and CHD in:

  1. 1.Removal of small molecules (e.g. urea), middle molecules (Beta-2 microglobulin, Phosphate and Creatinine) and protein bound solutes
  2. 2.Markers of inflammation, ossification and fibrosis
  3. 3.Uremia associated epigenetic modification The investigators hypothesize superiority of nutritional parameters in patients undergoing MCO dialysis compared with patients on CHD. The investigators plan to randomize 60 patients to either MCO dialysis or CHD at two hemodialysis units in Hong Kong.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

2 active sites

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

September 10, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

1.7 years

First QC Date

September 10, 2019

Last Update Submit

September 28, 2021

Conditions

End Stage Renal Failure on Dialysis

Outcome Measures

Primary Outcomes (2)

  • lean tissue index

    measured by Body Composition Monitor

    12 months

  • Body Mass Index

    measured by weight (in kilograms) divided by the square of heights (in meters)

    12 months

Secondary Outcomes (36)

  • asymmetrical dimethylarginine

    12 months

  • fibroblast growth factor 23

    12 months

  • Klotho

    12 months

  • Kt/V urea

    12 months

  • beta-2 microglobulin

    12 months

  • +31 more secondary outcomes

Study Arms (2)

Theranova

ACTIVE COMPARATOR

Patients will be receiving hemodialysis using Theranova dialyzer. The other hemodialysis parameters are kept the same.

Device: Theranova dialyzer

High-flux

ACTIVE COMPARATOR

Patients will be receiving hemodialysis using a high-flux dialyzer. The other hemodialysis parameters are kept the same

Device: High-flux dialyzer

Interventions

High-flux dialyzerDEVICE

a dialyzer meeting the definition of high-flux

High-flux
Theranova dialyzerDEVICE

a middle cut-off dialyzer

Theranova

Eligibility Criteria

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

You may qualify if:

  • adult patients age greater than 18 years old
  • end-stage renal failure on two- or three-times per week high-flux HD for more than 90 days
  • mean spKt/Vurea \>1.2 per session (for 3 dialysis sessions per week) or spKt/Vurea \>1.8 per session (for 2 dialysis sessions per week)

You may not qualify if:

  • active malignancy
  • unable to give informed consent or complete questionnaires
  • unstable clinical condition defined as significant clinical event requiring hospitalization in the past 90 days
  • unreliable vascular access
  • unable to achieve HD blood flow \>150ml/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Division of Nephrology, Department of Medicine, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Tung Wah Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Mok MMY, Yung S, Kwan LPY, Yip TPS, Lui SL, Chan TM. Expanded Hemodialysis with Theranova Compared with Conventional High-Flux Hemodialysis: Prospective Randomized 12-Month Study. Kidney360. 2025 Mar 18;6(7):1143-1157. doi: 10.34067/KID.0000000769.

    PMID: 40100276DERIVED

Study Officials

  • Maggie Ming Yee Mok, MBBS, MRCP

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The dialyzer used will be covered
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 10, 2019

First Posted

September 27, 2019

Study Start

November 1, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

HK(2)