HemodialysisNCT07265635
Functional Proteomics of Uremic Retention Solutes Associated With Immunosenescence, Inflammation and Impaired Adaptive Stress Response
A study testing HDF with PMMA and HDF in people with Hemodialysis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
This is a randomized controlled crossover trial (58) in order to characterize PBL damage and death rate in hemodialysis patients treated with membranes with different permeability, including protein-leaking dialysers. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis
- What is being tested?
- HDF with PMMA and HDF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 17 Feb 2025to 17 Feb 2027
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Male or female adults at time of enrolment aged <90 years old and >18 years old
- Patients in stable standard bicarbonate HD regimen, for at least two months
Who cannot join
- Patients aged <18 years old and >90 years old
- Known hypersensitivity or allergy to class of drugs or the investigational product or inability to comply with the requirements of the protocol;
- Participation in another study with investigational drug within the 30 days preceding and during the present study;
- Enrolment of the investigator, his/her family members, employees and other dependent persons;
- Recent illness (within the previous 1 week);
- Severe anemia (Hb < 7 g/dl);
- Bacterial or viral active infections;
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, 27100
About this study
This is a randomized controlled crossover trial (58) in order to characterize PBL damage and death rate in hemodialysis patients treated with membranes with different permeability, including protein-leaking dialysers.
The study will enroll fourty patients on regular 4-h three times per week hemodialysis (HD) of the dialysis unit of the "Fondazione IRCCS Policlinico San Matteo" (Pavia, Italy). Thirteen age and sex matched healthy individuals (Ctr) and ten CKD patients on peritoneal dialysis treatment (PD*) will be included as healthy and CKD-matched controls, respectively. Comparison between HD and PD patients is aimed to assess the effect of biocompatibility and protein leakage during the treatments
- Conditions
- Hemodialysis
- Being tested
- HDF with PMMA, HDF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDF with PMMADevice
Hemodiafiltration with polymethyl methacrylate (PMMA)-based membrane
HDFDevice
Hemodiafiltration without polymethyl methacrylate (PMMA)-based membrane
| Study group | Role | What they receive |
|---|---|---|
| patients on regular hemodialysis (HD) HDF with high cut-off polymethylmethacrylate (PMMA) membranes | Experimental | Not described Receives: Device: HDF with PMMA; Device: HDF |
| patients on regular hemodialysis (HD) with polysulfone membrane dialyzers (HDF) | Active comparator | Not described Receives: Device: HDF with PMMA; Device: HDF |
| healthy individuals | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the filters in term of the reduction of plasma HMWs and PBL death levels in a cross-over design
Measured: up to 24 months
Secondary outcomes (10)
Identification of plasma proteins composition of the uremic retentates.
Measured: day 0, day 90, day 180
Pharmacological manipulation of the cellular redox in THP-1 human leukocytes exposed to uremic retention solutes.
Thiol metabolomics and pharmacological manipulation of the cellular redox in THP-1 human leukocytes exposed to uremic retention solutes
Measured: day 0, day 90, day 180
Proteomics studies of the role of GSTP hyperexpression in the modulation of Nrf2 expression and activity in uremic leukocytes.
Measured: day 0, day 90, day 180
Study on transcription factors alternative to Nrf2
Study on transcription factors alternative to Nrf2 using human and murine Nrf2 inhibited monocyte lines
Measured: day 0, day 90, day 180
Study of Nrf2/GSTP stress response pathway in the PBL and THP-1 human monocytes
Study of expression and activity of the Nrf2/GSTP stress response pathway in the PBL and THP-1 human monocytes exposed to isolated uremic retention solutes.
Measured: day 0, day 90, day 180
Study of cell death in PBL freshly isolated from study groups
Study of cell death in PBL freshly isolated from study groups before and after treatment with autologous and heterologous whole plasma or isolated HMW fractions (studies of the IPR mechanism)
Measured: day 0, day 90, day 180
Analysis of CD4+ cells from blood samples and assessment of inflammatory cytokines after LPS stimulation
Purification and culture of CD4+ cells from blood samples and assessment of inflammatory cytokines (IL-4, IL-10, IL-12 p70, IL-18, and IFNγ) after LPS stimulation
Measured: day 0, day 90, day 180
Determination of lymphocyte subpopulations ex vivo
Measured: day 0, day 90, day 180
Pathway analysis of the differentially expressed proteins of PBL and of principal component of complement system
Measured: day 0, day 90, day 180
Analysis of HMWs characteristic oxidative PTMs in plasma and PBL lysate samples collected
Measured: day 0, day 90, day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start17 Feb 2025
- Primary completion17 Feb 2027 (estimated)
- Study completion17 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- This is a monocentric, randomized, controlled, crossover trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmelo Libetta, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265635
- Sponsor's protocol ID
- PROTEURS
- Status last verified
- Aug 2025
- First submitted
- 14 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Proteomics of Uremic Retention Solutes Associated With Immunosenescence, Inflammation and Impaired Adaptive Stress Response
- ClinicalTrials.gov ID
- NCT07265635
- Acronym / sponsor ID
- PROTEURS
- Conditions
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 17 Feb 2027 (estimated)
- Study completion
- 17 Feb 2027 (estimated)
- First posted
- 5 Dec 2025 (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 is a randomized controlled crossover trial (58) in order to characterize PBL damage and death rate in hemodialysis patients treated with membranes with different permeability, including protein-leaking dialysers.
The study will enroll fourty patients on regular 4-h three times per week hemodialysis (HD) of the dialysis unit of the "Fondazione IRCCS Policlinico San Matteo" (Pavia, Italy). Thirteen age and sex matched healthy individuals (Ctr) and ten CKD patients on peritoneal dialysis treatment (PD*) will be included as healthy and CKD-matched controls, respectively. Comparison between HD and PD patients is aimed to assess the effect of biocompatibility and protein leakage during the treatments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a monocentric, randomized, controlled, crossover trial
| Arm | Type | Receives |
|---|---|---|
| patients on regular hemodialysis (HD) HDF with high cut-off polymethylmethacrylate (PMMA) membranes | Experimental | Device: HDF with PMMA, Device: HDF |
| patients on regular hemodialysis (HD) with polysulfone membrane dialyzers (HDF) | Active comparator | Device: HDF with PMMA, Device: HDF |
| healthy individuals | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Male or female adults at time of enrolment aged <90 years old and >18 years old
- Patients in stable standard bicarbonate HD regimen, for at least two months
Key exclusion criteria (7 listed)
- Patients aged <18 years old and >90 years old
- Known hypersensitivity or allergy to class of drugs or the investigational product or inability to comply with the requirements of the protocol;
- Participation in another study with investigational drug within the 30 days preceding and during the present study;
- Enrolment of the investigator, his/her family members, employees and other dependent persons;
- Recent illness (within the previous 1 week);
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 |
|---|---|---|
| HDF with PMMAHemodiafiltration with polymethyl methacrylate (PMMA)-based membrane | Device | patients on regular hemodialysis (HD) HDF with high cut-off polymethylmethacrylate (PMMA) membranes, patients on regular hemodialysis (HD) with polysulfone membrane dialyzers (HDF) |
| HDFHemodiafiltration without polymethyl methacrylate (PMMA)-based membrane | Device | patients on regular hemodialysis (HD) HDF with high cut-off polymethylmethacrylate (PMMA) membranes, patients on regular hemodialysis (HD) with polysulfone membrane dialyzers (HDF) |
Primary outcome
Comparison of the filters in term of the reduction of plasma HMWs and PBL death levels in a cross-over design
Time frame: up to 24 months
10 secondary outcomes
Identification of plasma proteins composition of the uremic retentates.
Time frame: day 0, day 90, day 180
Pharmacological manipulation of the cellular redox in THP-1 human leukocytes exposed to uremic retention solutes.
Time frame: day 0, day 90, day 180
Proteomics studies of the role of GSTP hyperexpression in the modulation of Nrf2 expression and activity in uremic leukocytes.
Time frame: day 0, day 90, day 180
Study on transcription factors alternative to Nrf2
Time frame: day 0, day 90, day 180
Study of Nrf2/GSTP stress response pathway in the PBL and THP-1 human monocytes
Time frame: day 0, day 90, day 180
Study of cell death in PBL freshly isolated from study groups
Time frame: day 0, day 90, day 180
Analysis of CD4+ cells from blood samples and assessment of inflammatory cytokines after LPS stimulation
Time frame: day 0, day 90, day 180
Determination of lymphocyte subpopulations ex vivo
Time frame: day 0, day 90, day 180
Pathway analysis of the differentially expressed proteins of PBL and of principal component of complement system
Time frame: day 0, day 90, day 180
Analysis of HMWs characteristic oxidative PTMs in plasma and PBL lysate samples collected
Time frame: day 0, day 90, day 180
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 5 Dec 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HDF with PMMA and HDF in people with Hemodialysis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 5 Dec 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 Italy. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the filters in term of the reduction of plasma HMWs and PBL death levels in a cross-over design (time frame: up to 24 months). 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 5 Dec 2025.