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NCT06671535Recruiting

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

Source: ClinicalTrials.gov · Last updated 4 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
62 (estimated)
First submitted
31 Oct 2024
Start date
27 Jan 2025
Primary completion date
Jun 2025
Lead sponsor
Saint Petersburg State University, Russia
NCT number
NCT06671535

What you commit to

  • Study type: Interventional
  • Planned participants: 62
  • From 27 Jan 2025 to the primary completion date, Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Presence of active skin disease, cholestasis, severe secondary hyperparathyroidism and other conditions that, in the investigator's opinion, may be responsible for pruritus.

Other

  • Noncompliance of the patient with the protocol (in the investigator's opinion).
  • Use of haemodiafiltration.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Saint Petersburg State University Hospital
Coordinator of this site? Confirm its status
Saint PetersburgRussiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.