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

NCT06671535 | Recruiting

• 1 other identifier: PMMA and pruritis
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CKD (Chronic Kidney Disease) Stage 5D; Hemodialysis; Pruritis

Keywords

polymethylmethacrylate membranes; CKD-associated pruritis; PMMA membranes

Outcome Measures

Primary Outcomes (1)

• 5D Elman Itch Scale total score

  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 Outcomes (9)

• WI-NRS score

  From enrollment to the end of treatment at 8 weeks

• Skindex-16 score

  From enrollment to the end of treatment at 8 weeks

• Itch-MOS score

  From enrollment to the end of treatment at 8 weeks

• 5D Elman Itch Scale total score

  From the end of active treatment to the end of follow-up (4 weeks)

• WI-NRS score

  From the end of active treatment to the end of follow-up (4 weeks)

Study Arms (2)

PMMA arm

EXPERIMENTAL

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

Device: Polymethylmethacrylate membrane

Polysulfone arm

ACTIVE COMPARATOR

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

Device: polysulfone membranes

Interventions

Polymethylmethacrylate membrane DEVICE

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

PMMA arm

polysulfone membranes DEVICE

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

Polysulfone arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (1)

Saint Petersburg State University Hospital

Saint Petersburg, 198103, Russia

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Pruritus

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms

Central Study Contacts

Ekaterina Parshina, PhD

CONTACT

+7(921)6577372; pannn@yandex.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Nephrology and Dialysis department

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: January 27, 2025
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)