Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Polymethylmethacrylate membrane, polysulfone membranes.
- Who it may be relevant to
- Registry conditions: CKD (Chronic Kidney Disease) Stage 5D, Hemodialysis, Pruritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Polymethylmethacrylate membrane
A polymethylmethacrylate hollow fiber membrane (PMMA membrane) has unique properties including the uniform structure and the adsorption property. - Device polysulfone membranes
Dialyzers containing polysulfone membranes are widely used for modern dialysis therapies as they allow efficient removal of a broad spectrum of uremic toxins.
Primary outcome measures
- 5D Elman Itch Scale total score [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (9)
- WI-NRS score [Time frame: From enrollment to the end of treatment at 8 weeks]
- Skindex-16 score [Time frame: From enrollment to the end of treatment at 8 weeks]
- Itch-MOS score [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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- Saint Petersburg State University Hospital — Saint Petersburg
Identifiers
NCT: NCT06671535 · PMMA and pruritis