HDF with PMMA: Hemodiafiltration with polymethyl methacrylate (PMMA)-based membrane
HDF: Hemodiafiltration without polymethyl methacrylate (PMMA)-based membrane
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
Accepted
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;
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia
Pavia
More Fondazione IRCCS Policlinico San Matteo di Pavia trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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