An interventional study of Polymethylmethacrylate membrane and polysulfone membranes in CKD (Chronic Kidney Disease) Stage 5D, Hemodialysis and Pruritis, sponsored by Saint Petersburg State University, Russia. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Saint Petersburg State University, Russia · Not applicable, Interventional, and Treatment
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:
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's planned enrollment of 62 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Saint Petersburg State University, Russia is the lead sponsor of 34 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the experimental group will receive maintenance hemodialysis using polymetilmethacrylate membranes for 2 months.
Device: Polymethylmethacrylate membrane
Patients in the control group will receive maintenance hemodialysis using polysulfone membranes for 2 months.
Device: polysulfone membranes
A polymethylmethacrylate hollow fiber membrane (PMMA membrane) has unique properties including the uniform structure and the adsorption property.
Dialyzers containing polysulfone membranes are widely used for modern dialysis therapies as they allow efficient removal of a broad spectrum of uremic toxins.
5D Elman Itch Scale total score
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.
Time frame: From enrollment to the end of treatment at 8 weeks
WI-NRS score
24-hour Worst Itching Intensity Numerical Rating Scale
Time frame: From enrollment to the end of treatment at 8 weeks
Skindex-16 score
Multidimensional tool to assess pruritis
Time frame: From enrollment to the end of treatment at 8 weeks
Itch-MOS score
Itch-MOS questionnaire aims to evaluate impact of pruritis on sleep.
Time frame: From enrollment to the end of treatment at 8 weeks
5D Elman Itch Scale total score
Time frame: From the end of active treatment to the end of follow-up (4 weeks)
WI-NRS score
Time frame: From the end of active treatment to the end of follow-up (4 weeks)
Skindex-16 score
Time frame: From the end of active treatment to the end of follow-up (4 weeks)
Itch-MOS score
Time frame: From the end of active treatment to the end of follow-up (4 weeks)
C-reactive protein concentration
Time frame: From enrollment to the end of treatment at 8 weeks
Serum ferritin
Time frame: From enrollment to the end of treatment at 8 weeks
Plan to share: No
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Saint Petersburg State University, Russia