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

Обзор

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.

Вмешательства

• Устройство Polymethylmethacrylate membrane
  A polymethylmethacrylate hollow fiber membrane (PMMA membrane) has unique properties including the uniform structure and the adsorption property.
• Устройство polysulfone membranes
  Dialyzers containing polysulfone membranes are widely used for modern dialysis therapies as they allow efficient removal of a broad spectrum of uremic toxins.

Первичные конечные точки

• 5D Elman Itch Scale total score [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (9)

• WI-NRS score [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Skindex-16 score [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Itch-MOS score [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• 5D Elman Itch Scale total score [Срок оценки: From the end of active treatment to the end of follow-up (4 weeks)]
• WI-NRS score [Срок оценки: From the end of active treatment to the end of follow-up (4 weeks)]
• Skindex-16 score [Срок оценки: From the end of active treatment to the end of follow-up (4 weeks)]
• Itch-MOS score [Срок оценки: From the end of active treatment to the end of follow-up (4 weeks)]
• C-reactive protein concentration [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Serum ferritin [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Россия · 1 центр

• Saint Petersburg State University Hospital — Saint Petersburg

Идентификаторы

NCT: NCT06671535 · PMMA and pruritis

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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