RecruitingNot ApplicableNCT06671535

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

Sponsor

Saint Petersburg State University, Russia

Enrollment

62 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

Hemodialysis CKD (Chronic Kidney Disease) Stage 5D Pruritis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria3

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.

Interventions

DEVICEPolymethylmethacrylate membrane

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

DEVICEpolysulfone membranes

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