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 (HD-1)

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Dialysis Amyloidosis; Hemodialysis-Associated Amyloidosis
• Intervention / Treatment: Device: Theranova 400; Device: Elisio-19H

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Selangor Darul Ehsan
    • Batu Caves, Selangor Darul Ehsan, Malaysia, 68100
      • Selayang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 years of age or above
2. End stage kidney failure receiving hemodialysis for at least 3 years
3. Currently receiving hemodialysis at our center regularly
4. Written informed consent

Exclusion Criteria:

1. Patients with hemodiafiltration
2. Catheter-related blood stream infection in the preceding 4 weeks
3. Malfunctioning of HD catheter
4. Planned transfer to peritoneal dialysis or transplant within 90 days
5. Pregnancy
6. History of active alcohol or substance abuse in the previous 6 months
7. Concurrent participation in another interventional study
8. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MCO Dialyser; 12 treatments (4 weeks) with Medium Cut-Off Dialyzer	Device: Theranova 400; medium cut-off dialyser
Active Comparator: High Flux Dialyser; 12 treatments (4 weeks) with High Flux Dialyzer	Device: Elisio-19H; high flux dialyser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory state after intervention	Changes to C-Reactive Protein Level	4 weeks
Changes to Quality of Life	Changes to Quality of life Using EQ-5D-5L	27 weeks

Collaborators and Investigators

• Sponsor: Selayang Hospital
• Investigators: Study Director: Hin Seng Wong, MD, Ministry of Health, Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 9, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Quality of Life; Hemodialysis-Associated Amyloidosis; Dialysis Amyloidosis
• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis
• Other Study ID Numbers: HS/CTP/HD/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No