Functional Proteomics of Uremic Retention Solutes Associated With Immunosenescence, Inflammation and Impaired Adaptive Stress Response

NCT07265635 | Active Not Recruiting

• 1 other identifier: PROTEURS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Comparison of the filters in term of the reduction of plasma HMWs and PBL death levels in a cross-over design

  up to 24 months

Secondary Outcomes (10)

• Identification of plasma proteins composition of the uremic retentates.

  day 0, day 90, day 180

• Pharmacological manipulation of the cellular redox in THP-1 human leukocytes exposed to uremic retention solutes.

  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.

  day 0, day 90, day 180

• Study on transcription factors alternative to Nrf2

  day 0, day 90, day 180

• Study of Nrf2/GSTP stress response pathway in the PBL and THP-1 human monocytes

  day 0, day 90, day 180

Study Arms (3)

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

Interventions

HDF DEVICE

Hemodiafiltration without polymethyl methacrylate (PMMA)-based membrane

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

HDF with PMMA DEVICE

Hemodiafiltration with polymethyl methacrylate (PMMA)-based membrane

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, 27100, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Carmelo Libetta

Model Details: This is a monocentric, randomized, controlled, crossover trial

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 5, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): February 17, 2027
• Study Completion (Estimated): February 17, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-08

Locations

IT (1)