Using special dialysis membranes to reduce itching in kidney patients
Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis
This study is testing if special dialysis membranes can help reduce itching in patients with advanced kidney disease who are on hemodialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Saint Petersburg State University, Russia Academic / other |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT06671535 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of polymethylmethacrylate (PMMA) membranes in reducing pruritus in patients with chronic kidney disease stage 5D undergoing maintenance hemodialysis. Participants will be randomly assigned to receive either PMMA or standard polysulfone membranes for a duration of two months. Throughout the study, patients will complete questionnaires to assess the intensity of their itching and its impact on their quality of life. The goal is to determine if PMMA membranes can significantly alleviate moderate-to-severe pruritus compared to traditional membranes.
Who should consider this trial
Good fit: Ideal candidates are patients with chronic kidney disease stage 5D who have been on maintenance hemodialysis for at least three months and experience moderate-to-severe pruritus.
Not a fit: Patients with active skin diseases or other conditions causing pruritus unrelated to kidney disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved quality of life for dialysis patients suffering from severe itching.
How similar studies have performed: While the use of PMMA membranes is a novel approach, similar studies have shown promise in addressing pruritus in dialysis patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Saint Petersburg
- Saint Petersburg State University Hospital — Saint Petersburg, Russia (Recruiting)
Study contacts
- Study coordinator: Ekaterina Parshina, PhD
- Email: pannn@yandex.ru
- Phone: +7(921)6577372
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.