NCT06671535 Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis
| NCT ID | NCT06671535 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Saint Petersburg State University, Russia |
| Condition | CKD (Chronic Kidney Disease) Stage 5D |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2025-01-27 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06671535 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CKD (Chronic Kidney Disease) Stage 5D. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06671535 currently recruiting?
Yes, NCT06671535 is actively recruiting participants. Contact the research team at pannn@yandex.ru for enrollment information.
Where is the NCT06671535 trial being conducted?
This trial is being conducted at Saint Petersburg, Russia.
Who is sponsoring the NCT06671535 clinical trial?
NCT06671535 is sponsored by Saint Petersburg State University, Russia. The trial plans to enroll 62 participants.
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