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OpenTrials
Completed

NCT Number: NCT04160351

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selayang Hospital

Batu Caves, Selangor, 68100, Malaysia

About this study

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

Patients who are initially on High Flux Dialyser will be randomised into either MCO Dialyser (modality A) or High Flux Dialyser (modality B) dialysate. The dialysate flow (QD) and blood flow (QB) remains unchanged throughout study period. After 12 treatments (4 weeks) a 4-weeks wash-out phase using High-flux dialyzers was performed to minimize carry-over-effects. After the 4-weeks washout phase, the modality is switched to the alternative one for 8 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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

Exclusion criteria

  • 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

Treatment and study plan

Theranova 400

Device

medium cut-off dialyser

Elisio-19H

Device

high flux dialyser

Primary outcomes

  1. Removal of Beta-2-microglobulin

    Time frame: 4 weeks

    Changes to Beta-2-microglobulin level

  2. Changes to Quality of Life

    Time frame: 27 weeks

    Changes to Quality of life Using SF-36

Secondary outcomes

  1. Inflammatory state after intervention

    Time frame: 4 weeks

    Changes to C-Reactive Protein Level

  2. Changes to Quality of Life

    Time frame: 27 weeks

    Changes to Quality of life Using EQ-5D-5L

Sponsors and collaborators

Lead sponsor

Selayang Hospital

Other Gov

Registry information

Official study title

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 In Removing Beta-2- Microglobulin Among Patients With End-Stage Kidney Disease On Chronic Haemodialysis

Acronym: HD-1

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Nov 13, 2019
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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