CompletedPhase 2

Evaluation Of A New Vitamin E-Bonded Membrane On Anemia And Oxidative Stress In End-Stage Renal Disease Patients

Italy20 participantsStarted 2006-07

Plain-language 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 purpose we will consider the effect of VitabranE on inflammation and oxidative stress parameters as a function of the changes observed in the anemia parameters.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. One of the following condition in the last 3 months :
✕. 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

What they're measuring

The primary outcome measure will be the ESA resistance index, a combined variable calculated by dividing the weekly ESA dose by haemoglobin level and end-dialysis body weight.

Timeframe: every other month

Trial details

NCT IDNCT00687258

SponsorA. Manzoni Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-03

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