Actively Recruiting
Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis
Led by Saint Petersburg State University, Russia · Updated on 2025-03-04
62
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of polymethylmethacrylate (PMMA) dialysis membranes on the intensity of itching (pruritus) in patients with chronic kidney disease (CKD) stage 5D who are receiving maintenance hemodialysis. The trial compares PMMA membranes to standard polysulfone membranes to see if PMMA can reduce moderate-to-severe itching and improve quality of life related to pruritus. Participants will be randomly assigned to receive maintenance hemodialysis using either PMMA membranes or polysulfone membranes for 2 months. The PMMA membrane is a device with unique adsorption properties, while polysulfone membranes are widely used for effective removal of toxins during dialysis. Each group undergoes their assigned treatment over the study period. During the study, participants will complete questionnaires measuring the intensity of itching and its impact on daily life. Researchers will assess outcomes using the 5D Elman Itch Scale and other itch-related scores from enrollment through 8 weeks of treatment and during 4 weeks of follow-up. Blood tests for inflammation and iron stores will also be monitored. The study runs from January 2025 to October 2025, with all visits and assessments designed to track the effects of the dialysis membranes on pruritus.
CONDITIONS
Brief Title
Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of CKD stage 5D with maintenance hemodialysis for at least 3 months before screening
- Moderate-to-severe pruritis with a WI-NRS score of 4 or higher
- Adequate dialysis dose (spKt/V at least 1.4 and/or eKt/V at least 1.2)
- Dialysis treatment regimen of three sessions per week lasting at least 4 hours each
- Signed informed consent
You will not qualify if you...
- Active skin disease, cholestasis, severe secondary hyperparathyroidism, or other conditions possibly causing pruritus
- Patient noncompliance with the study protocol
- Use of haemodiafiltration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants receive kidney replacement therapy using either polymethylmethacrylate membranes or polysulfone membranes during maintenance hemodialysis.
Three dialysis sessions per week
Duration - 4 weeks
Participants are monitored after the end of active treatment to assess pruritus-related quality of life and other health measures.
Periodic assessments during follow-up
Trial Site Locations
Total: 1 location
1
Saint Petersburg State University Hospital
Saint Petersburg, Russia, 198103
Actively Recruiting
Research Team
E
Ekaterina Parshina, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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