patients on chronic hemodialysis MedDRA version: 9.1 Level: LLT Classification code 10014647
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Erythropoietin
Concentration type: equal
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Darbepoetin alfa
Concentrati
Sponsors
AZIENDA UNITA` SANITARIA LOCALE N 12 DI VIAREGGIO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be included in this experimental study, patients must meet all following criteria: 3 1. Signing of informed consent. 2. Prevalent chronic hemodialysis patients treated for at least 3 months with BHD HDF or online; 3. Use of biocompatible membranes; 4. Being treated with ESAs (any molecule); 5. Values of Hb between 9-13 g / dl and TSAT (transferrin saturation) between 20 -- 40%. 6. Carriers FAV (arteriovenous fistula) or prosthetic vascular access as vascular hemodialysis. 7. Over 18 years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with these characteristics will be excluded from the study: 1. Bearers of central venous catheter; 2. Vascular access with Qb (blood flow) <300 ml / min; 3. Patients with acute infectious processes local or systemic 4. Active malignant neoplasm (excluding non-melanoma skin cancers) 5. History of autoimmune disease, treatment with corticosteroids, 6. Transfusions in the 2 months prior to entering the study, 7. Hemolysis, hemoglobinopathies, myelopathy, 8. Patients with metal implants or metal implants (they are allowed plants dental and piercings) 9. Abuse of drugs or alcohol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the role of HDF on line compared to bicarbonate dialysis on resistance to erythropoiesis stimulating agents;Secondary Objective: Evaluate the effects of on-line HDF on inflammatory markers; Assess the relationship between hepcidin, IL-6, chronic inflammation and resistance to ESAs. Monitoring the state of hydratation and nutrition of patients using the BCM (Body Composition) Fresenius Medical Care) that can detect patients at risk and educate them about salt and water intake and a proper nutrition.;Primary end point(s): Primary end point of this study is the evaluation of plasma changes of Hepcidin in the two different dialysis techniques (HDF on line and BHD) and their effect of ESAs resistance | — |
Countries
Italy
Outcome results
None listed