Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis

March 2, 2025 updated by: Ekaterina Parshina, Saint Petersburg State University, Russia

This randomized controlled trial aims to evaluate the effect of polymethylmethacrylate dialysis membranes use on the intensity of pruritus in patients with CKD stage 5D receiving maintenance hemodialysis.

The main question it aims to answer is: Does the use of polymethylmethacrylate (PMMA) membranes reduce the intensity of pruritus in dialysis patients?

Researchers will compare PMMA membranes to standard polysulfone-based membranes to see if PMMA works to reduce moderate-to-severe pruritis and pruritis-related quality of life.

Participants will:

  • receive maintenance hemodialysis with PMMA or polysulfone membranes for 2 months;
  • fill in questionnaires about intensity of pruritis and its impact on daily life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ekaterina Parshina, PhD
  • Phone Number: +7(921)6577372
  • Email: pannn@yandex.ru

Study Locations

  • Russian Federation
      • Saint-Petersburg, Russian Federation, 198103
        • Recruiting
        • Saint Petersburg State University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of CKD stage 5D, maintenance hemodialysis not less than 3 months prior screening;
  • Moderate-to-severe pruritis (WI-NRS score ≥ 4);
  • Adequate dialysis dose (spKt/V≥1,4 and/or eKt/V≥1,2);
  • Dialysis treatment regimen: three sessions per week of at least 4 hours duration;
  • Signed informed consent.

Exclusion Criteria:

  • Presence of active skin disease, cholestasis, severe secondary hyperparathyroidism and other conditions that, in the investigator's opinion, may be responsible for pruritus.
  • Noncompliance of the patient with the protocol (in the investigator's opinion).
  • Use of haemodiafiltration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PMMA arm
Patients in the experimental group will receive maintenance hemodialysis using polymetilmethacrylate membranes for 2 months.
Device: Polymethylmethacrylate membrane
A polymethylmethacrylate hollow fiber membrane (PMMA membrane) has unique properties including the uniform structure and the adsorption property.
Active Comparator: Polysulfone arm
Patients in the control group will receive maintenance hemodialysis using polysulfone membranes for 2 months.
Device: polysulfone membranes
Dialyzers containing polysulfone membranes are widely used for modern dialysis therapies as they allow efficient removal of a broad spectrum of uremic toxins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5D Elman Itch Scale total score
Time Frame: From enrollment to the end of treatment at 8 weeks
The 5-D itch scale is a reliable, multidimensional measure of itching that has been validated in patients with chronic pruritus to able to detect changes over time. This questionnaire was designed to be useful as an outcome measure in clinical trials. The five dimensions are degree, duration, direction, disability and distribution.
From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WI-NRS score
Time Frame: From enrollment to the end of treatment at 8 weeks
24-hour Worst Itching Intensity Numerical Rating Scale
From enrollment to the end of treatment at 8 weeks
Skindex-16 score
Time Frame: From enrollment to the end of treatment at 8 weeks
Multidimensional tool to assess pruritis
From enrollment to the end of treatment at 8 weeks
Itch-MOS score
Time Frame: From enrollment to the end of treatment at 8 weeks
Itch-MOS questionnaire aims to evaluate impact of pruritis on sleep.
From enrollment to the end of treatment at 8 weeks
5D Elman Itch Scale total score
Time Frame: From the end of active treatment to the end of follow-up (4 weeks)
From the end of active treatment to the end of follow-up (4 weeks)
WI-NRS score
Time Frame: From the end of active treatment to the end of follow-up (4 weeks)
From the end of active treatment to the end of follow-up (4 weeks)
Skindex-16 score
Time Frame: From the end of active treatment to the end of follow-up (4 weeks)
From the end of active treatment to the end of follow-up (4 weeks)
Itch-MOS score
Time Frame: From the end of active treatment to the end of follow-up (4 weeks)
From the end of active treatment to the end of follow-up (4 weeks)
C-reactive protein concentration
Time Frame: From enrollment to the end of treatment at 8 weeks
From enrollment to the end of treatment at 8 weeks
Serum ferritin
Time Frame: From enrollment to the end of treatment at 8 weeks
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Petersburg State University, Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2025

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

October 31, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Actual)

November 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 2, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMMA and pruritis

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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