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

N/AActive Not RecruitingNCT07265635

Fondazione IRCCS Policlinico San Matteo di Pavia30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hemodialysis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

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