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

Not Applicable

Recruiting

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

• Registration Number: NCT06671535
• Lead Sponsor: Saint Petersburg State University, Russia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-31
• Study First Submitted QC: 2024-10-31
• Study First Posted: 2024-11-04
• Study Start: 2025-01-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-02
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-06
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
5D Elman Itch Scale total score	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.

Secondary Outcome Measures

Name	Time	Method
WI-NRS score	From the end of active treatment to the end of follow-up (4 weeks)
Skindex-16 score	From the end of active treatment to the end of follow-up (4 weeks)
Itch-MOS score	From the end of active treatment to the end of follow-up (4 weeks)
5D Elman Itch Scale total score	From the end of active treatment to the end of follow-up (4 weeks)
C-reactive protein concentration	From enrollment to the end of treatment at 8 weeks
Serum ferritin	From enrollment to the end of treatment at 8 weeks

Trial Locations

Locations (1)

Saint Petersburg State University Hospital; 🇷🇺 Saint-Petersburg, Russian Federation