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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-17

Study Completion Date

2027-02-17

Brief Summary

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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

Detailed Description

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Conditions

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Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a monocentric, randomized, controlled, crossover trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients on regular hemodialysis (HD) HDF with high cut-off polymethylmethacrylate (PMMA) membranes

Group Type EXPERIMENTAL

HDF with PMMA

Intervention Type DEVICE

Hemodiafiltration with polymethyl methacrylate (PMMA)-based membrane

HDF

Intervention Type DEVICE

Hemodiafiltration without polymethyl methacrylate (PMMA)-based membrane

patients on regular hemodialysis (HD) with polysulfone membrane dialyzers (HDF)

Group Type ACTIVE_COMPARATOR

HDF with PMMA

Intervention Type DEVICE

Hemodiafiltration with polymethyl methacrylate (PMMA)-based membrane

HDF

Intervention Type DEVICE

Hemodiafiltration without polymethyl methacrylate (PMMA)-based membrane

healthy individuals

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HDF with PMMA

Hemodiafiltration with polymethyl methacrylate (PMMA)-based membrane

Intervention Type DEVICE

HDF

Hemodiafiltration without polymethyl methacrylate (PMMA)-based membrane

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Carmelo Libetta

Carmelo Libetta

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, Italy

Site Status

Countries

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Italy

Other Identifiers

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PROTEURS

Identifier Type: -

Identifier Source: org_study_id

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