Status:
COMPLETED
Evaluation Of A New Vitamin E-Bonded Membrane On Anemia And Oxidative Stress In End-Stage Renal Disease Patients
Lead Sponsor:
A. Manzoni Hospital
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The main purpose of this longitudinal study is to point out the effect of VitabranE on the ESA resistance and on the anemia observed in HD patients undergoing EPO maintenance therapy. As a secondary ...
Detailed Description
Aim The aim of this pilot randomized study is to verify whether the addition of vitamin E alpha-tocopherol to the blood-side layer of a synthetic polysulfone dialyser membrane has a clinical advantag...
Eligibility Criteria
Inclusion
- Male and female patients, aged ≥ 18, stabilized on BHD for at least 6 months.
- Clinical stability during the last 3 months.
- Serum Ferritin \> 200 mg/L and Transferrin saturation \>30%.
- Maintenance therapy with epoetin alfa/beta or darbepoetin alfa.
Exclusion
- One of the following condition in the last 3 months :
- acute infection
- vascular access thrombosis
- ictus cerebri
- myocardial stroke
- haemorrhage
- major surgery
- haemo-transfusion
- Haemoglobinopaty, sickle cell anemia, familial erythroblastic anemia and any other haematological disorder interfering with the aim of the study
- Malignancy
- Participation to other studies or use of EPO analogues not yet commercialized
- pharmacological dosage administration of antioxidant supplements
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00687258
Start Date
July 1 2006
End Date
July 1 2007
Last Update
September 25 2020
Active Locations (1)
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1
Alessandro Manzoni Hospital, Nephrology and Dialysis Department
Lecco, Italy, 23900