Role of on-line hemodiafiltration (HDF) in the modulation of resistance to erythropoiesis stimulating agents (REDERT) - ND

• Conditions: patients on chronic hemodialysis; MedDRA version: 9.1Level: LLTClassification code 10014647

• Registration Number: EUCTR2010-018718-57-IT
• Lead Sponsor: AZIENDA UNITA` SANITARIA LOCALE N 12 DI VIAREGGIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-12
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified