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

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Active, not recruiting

Conditions

Hemodialysis

Treatments

Device: HDF

Device: HDF with PMMA

Study type

Interventional

Funder types

Other

Identifiers

NCT07265635

PROTEURS

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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;