Functional Proteomics of Uremic Retention Solutes Associated With Immunosenescence, Inflammation and Impaired Adaptive Stress Response
NCT ID: NCT07265635
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-02-17
2027-02-17
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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patients on regular hemodialysis (HD) HDF with high cut-off polymethylmethacrylate (PMMA) membranes
HDF with PMMA
Hemodiafiltration with polymethyl methacrylate (PMMA)-based membrane
HDF
Hemodiafiltration without polymethyl methacrylate (PMMA)-based membrane
patients on regular hemodialysis (HD) with polysulfone membrane dialyzers (HDF)
HDF with PMMA
Hemodiafiltration with polymethyl methacrylate (PMMA)-based membrane
HDF
Hemodiafiltration without polymethyl methacrylate (PMMA)-based membrane
healthy individuals
No interventions assigned to this group
Interventions
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HDF with PMMA
Hemodiafiltration with polymethyl methacrylate (PMMA)-based membrane
HDF
Hemodiafiltration without polymethyl methacrylate (PMMA)-based membrane
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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;
18 Years
90 Years
ALL
Yes
Sponsors
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Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Responsible Party
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Carmelo Libetta
Carmelo Libetta
Locations
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Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, Italy
Countries
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Other Identifiers
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PROTEURS
Identifier Type: -
Identifier Source: org_study_id
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