A Randomised, Open-Label, Cross Over Group, Single-Centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-Off Membrane Dialyser Compared With High Flux Dialyser Among Patients With Chronic Haemodialysis

NCT04160351 | Completed

• 1 other identifier: HS/CTP/HD/001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.

Conditions

Hemodialysis-Associated Amyloidosis; Dialysis Amyloidosis; Quality of Life

Keywords

Hemodialysis-Associated Amyloidosis; Dialysis Amyloidosis; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Removal of Beta-2-microglobulin

  Changes to Beta-2-microglobulin level

  4 weeks

• Changes to Quality of Life

  Changes to Quality of life Using SF-36

  27 weeks

Secondary Outcomes (2)

• Inflammatory state after intervention

  4 weeks

• Changes to Quality of Life

  27 weeks

Study Arms (2)

MCO Dialyser

EXPERIMENTAL

12 treatments (4 weeks) with Medium Cut-Off Dialyzer

Device: Theranova 400

High Flux Dialyser

ACTIVE COMPARATOR

12 treatments (4 weeks) with High Flux Dialyzer

Device: Elisio-19H

Interventions

Theranova 400 DEVICE

medium cut-off dialyser

MCO Dialyser

Elisio-19H DEVICE

high flux dialyser

High Flux Dialyser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or above
• End stage kidney failure receiving hemodialysis for at least 3 years
• Currently receiving hemodialysis at our center regularly
• Written informed consent

You may not qualify if:

• Patients with hemodiafiltration
• Catheter-related blood stream infection in the preceding 4 weeks
• Malfunctioning of HD catheter
• Planned transfer to peritoneal dialysis or transplant within 90 days
• Pregnancy
• History of active alcohol or substance abuse in the previous 6 months
• Concurrent participation in another interventional study
• Other medical condition which, in the investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes

Sponsors & Collaborators

• Selayang Hospital: lead

Study Sites (1)

Selayang Hospital

Batu Caves, Selangor, 68100, Malaysia

Location

Study Officials

• Hin Seng Wong, MD

  Ministry of Health, Malaysia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is an open label, cross-over group, single-centre randomised controlled trial comparing MCO Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 13, 2019
• Study Start: December 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: December 31, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)