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

NCT ID: NCT06671535

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-27

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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CKD (Chronic Kidney Disease) Stage 5D Hemodialysis Pruritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PMMA arm

Patients in the experimental group will receive maintenance hemodialysis using polymetilmethacrylate membranes for 2 months.

Group Type EXPERIMENTAL

Polymethylmethacrylate membrane

Intervention Type DEVICE

A polymethylmethacrylate hollow fiber membrane (PMMA membrane) has unique properties including the uniform structure and the adsorption property.

Polysulfone arm

Patients in the control group will receive maintenance hemodialysis using polysulfone membranes for 2 months.

Group Type ACTIVE_COMPARATOR

polysulfone membranes

Intervention Type DEVICE

Dialyzers containing polysulfone membranes are widely used for modern dialysis therapies as they allow efficient removal of a broad spectrum of uremic toxins.

Interventions

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Polymethylmethacrylate membrane

A polymethylmethacrylate hollow fiber membrane (PMMA membrane) has unique properties including the uniform structure and the adsorption property.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint Petersburg State University, Russia

OTHER

Sponsor Role lead

Responsible Party

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Ekaterina Parshina

Chief of Nephrology and Dialysis department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Saint Petersburg State University Hospital

Saint Petersburg, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Ekaterina Parshina, PhD

Role: CONTACT

+7(921)6577372

Facility Contacts

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Ekaterina PARSHINA, PhD

Role: primary

89216577372

Alexey Tolkach, MD

Role: backup

Other Identifiers

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PMMA and pruritis

Identifier Type: -

Identifier Source: org_study_id

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