CKD (Chronic Kidney Disease) Stage 5DNCT06671535
Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis
A study testing Polymethylmethacrylate membrane and polysulfone membranes in people with CKD (Chronic Kidney Disease) Stage 5D and Hemodialysis, run by Saint Petersburg State University, Russia at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD (Chronic Kidney Disease) Stage 5D, Hemodialysis, Pruritis
- What is being tested?
- Polymethylmethacrylate membrane and polysulfone membranes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteRussia
- Study dates
- 27 Jan 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Saint Petersburg State University Hospital
Saint Petersburg, 198103
Ekaterina PARSHINA, PhD, 89216577372, pannn@yandex.ru
Alexey Tolkach, MD, ab2769@mail.ru
About this study
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?
Read more
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.
- Being tested
- Polymethylmethacrylate membrane, polysulfone membranes
- Keywords
- polymethylmethacrylate membranes, CKD-associated pruritis, PMMA membranes
- Medical subject headings
- Renal Insufficiency, Chronic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymethylmethacrylate membraneDevice
A polymethylmethacrylate hollow fiber membrane (PMMA membrane) has unique properties including the uniform structure and the adsorption property.
polysulfone membranesDevice
Dialyzers containing polysulfone membranes are widely used for modern dialysis therapies as they allow efficient removal of a broad spectrum of uremic toxins.
| Study group | Role | What they receive |
|---|---|---|
| PMMA arm | Experimental | Patients in the experimental group will receive maintenance hemodialysis using polymetilmethacrylate membranes for 2 months. Receives: Device: Polymethylmethacrylate membrane |
| Polysulfone arm | Active comparator | Patients in the control group will receive maintenance hemodialysis using polysulfone membranes for 2 months. Receives: Device: polysulfone membranes |
What is being measured
The primary outcome is the main question the study is designed to answer.
5D Elman Itch Scale total score
The 5-D itch scale is a reliable, multidimensional measure of itching that has been validated in patients with chronic pruritus to able to detect changes over time. This questionnaire was designed to be useful as an outcome measure in clinical trials. The five dimensions are degree, duration, direction, disability and distribution.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (9)
WI-NRS score
24-hour Worst Itching Intensity Numerical Rating Scale
Measured: From enrollment to the end of treatment at 8 weeks
Skindex-16 score
Multidimensional tool to assess pruritis
Measured: From enrollment to the end of treatment at 8 weeks
Itch-MOS score
Itch-MOS questionnaire aims to evaluate impact of pruritis on sleep.
Measured: From enrollment to the end of treatment at 8 weeks
5D Elman Itch Scale total score
Measured: From the end of active treatment to the end of follow-up (4 weeks)
WI-NRS score
Measured: From the end of active treatment to the end of follow-up (4 weeks)
Skindex-16 score
Measured: From the end of active treatment to the end of follow-up (4 weeks)
Itch-MOS score
Measured: From the end of active treatment to the end of follow-up (4 weeks)
C-reactive protein concentration
Measured: From enrollment to the end of treatment at 8 weeks
Serum ferritin
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start27 Jan 2025
- Primary completionJun 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKD (Chronic Kidney Disease) Stage 5DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekaterina Parshina, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671535
- Sponsor's protocol ID
- PMMA and pruritis
- Status last verified
- Mar 2025
- First submitted
- 31 Oct 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kidney Replacement Therapy with Polymethylmethacrylate Membranes on Pruritus-related Quality of Life in Patients Receiving Maintenance Haemodialysis
- ClinicalTrials.gov ID
- NCT06671535
- Acronym / sponsor ID
- PMMA and pruritis
- Keywords
- polymethylmethacrylate membranes, CKD-associated pruritis, PMMA membranes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMMA arm | Experimental | Device: Polymethylmethacrylate membranePatients in the experimental group will receive maintenance hemodialysis using polymetilmethacrylate membranes for 2 months. |
| Polysulfone arm | Active comparator | Device: polysulfone membranesPatients in the control group will receive maintenance hemodialysis using polysulfone membranes for 2 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polymethylmethacrylate membraneA polymethylmethacrylate hollow fiber membrane (PMMA membrane) has unique properties including the uniform structure and the adsorption property. | Device | PMMA arm |
| polysulfone membranesDialyzers containing polysulfone membranes are widely used for modern dialysis therapies as they allow efficient removal of a broad spectrum of uremic toxins. | Device | Polysulfone arm |
Primary outcome
5D Elman Itch Scale total score
Time frame: From enrollment to the end of treatment at 8 weeks
The 5-D itch scale is a reliable, multidimensional measure of itching that has been validated in patients with chronic pruritus to able to detect changes over time. This questionnaire was designed to be useful as an outcome measure in clinical trials. The five dimensions are degree, duration, direction, disability and distribution.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymethylmethacrylate membrane and polysulfone membranes in people with CKD (Chronic Kidney Disease) Stage 5D and Hemodialysis, run by Saint Petersburg State University, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ekaterina Parshina, PhD (+7(921)6577372, pannn@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5D Elman Itch Scale total score (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.