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NCT Number: NCT07265635

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hemodialysis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

HDF with PMMA

Device

Hemodiafiltration with polymethyl methacrylate (PMMA)-based membrane

HDF

Device

Hemodiafiltration without polymethyl methacrylate (PMMA)-based membrane

Primary outcomes

  1. 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

Secondary outcomes

  1. Identification of plasma proteins composition of the uremic retentates.

    Time frame: day 0, day 90, day 180

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

    Time frame: day 0, day 90, day 180

    Thiol metabolomics and pharmacological manipulation of the cellular redox in THP-1 human leukocytes exposed to uremic retention solutes

  3. 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

  4. Study on transcription factors alternative to Nrf2

    Time frame: day 0, day 90, day 180

    Study on transcription factors alternative to Nrf2 using human and murine Nrf2 inhibited monocyte lines

  5. 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 expression and activity of the Nrf2/GSTP stress response pathway in the PBL and THP-1 human monocytes exposed to isolated uremic retention solutes.

  6. Study of cell death in PBL freshly isolated from study groups

    Time frame: day 0, day 90, day 180

    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)

  7. Analysis of CD4+ cells from blood samples and assessment of inflammatory cytokines after LPS stimulation

    Time frame: day 0, day 90, day 180

    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

  8. Determination of lymphocyte subpopulations ex vivo

    Time frame: day 0, day 90, day 180

  9. Pathway analysis of the differentially expressed proteins of PBL and of principal component of complement system

    Time frame: day 0, day 90, day 180

  10. Analysis of HMWs characteristic oxidative PTMs in plasma and PBL lysate samples collected

    Time frame: day 0, day 90, day 180

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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