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

Saint Petersburg State University, Russia

Status: Enrolling

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

Treatments: Device: Polymethylmethacrylate membrane; Device: polysulfone membranes

Study type: Interventional

Funder types: Other

Identifiers

NCT06671535

PMMA and pruritis

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

PMMA arm

Experimental group

Description:

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

Treatment:

Device: Polymethylmethacrylate membrane

Polysulfone arm

Active Comparator group

Description:

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

Treatment:

Device: polysulfone membranes