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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaint Petersburg State University, Russia

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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

Treatments tested in this trial

  • Polymethylmethacrylate membrane
  • polysulfone membranes

Treatment groups

62 Participants
are divided into 2 treatment groups