Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis
Recruiting · NCT06671535 · Interventional (participants receive a specific treatment) · Lead sponsor: Saint Petersburg State University, Russia
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Saint Petersburg State University Hospital - Saint Petersburg, Russia