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

NCT00687258 | Completed Phase 2 DMC

• 1 other identifier: Vit E-Rif01-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Anemia

Keywords

Anemia; Oxidative Stress; Erythropoietin; dialyser membrane; Vitamin E; Erythropoietin responsiveness; Erythropoietin resistance; hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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.

  every other month

Secondary Outcomes (1)

• Inflammatory status (CRP and IL-6) and oxidative stress markers (Vitamin E levels, TAC, Protein carbonyls and AOPP, AGEs).

  every other month

Study Arms (2)

1

EXPERIMENTAL

VitabranE ViE: Vitamin E-bonded polysulfone dialyzer

Device: VitabranE ViE

2

NO INTERVENTION

APS-U (Asahi Polysulfone APS): Polysulfone dialyzer

Interventions

VitabranE ViE DEVICE

Polysulfone dialyser with vitamin E alpha-tocopherol

Also known as: Vitamin E-bonded polysulfone dialyzer

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• A. Manzoni Hospital: lead

Study Sites (1)

Alessandro Manzoni Hospital, Nephrology and Dialysis Department

Lecco, 23900, Italy

Location

Related Publications (1)

• Andrulli S, Di Filippo S, Manzoni C, Stefanelli L, Floridi A, Galli F, Locatelli F. Effect of synthetic vitamin E-bonded membrane on responsiveness to erythropoiesis-stimulating agents in hemodialysis patients: a pilot study. Nephron Clin Pract. 2010;115(1):c82-9. doi: 10.1159/000294281. Epub 2010 Mar 8.

  PMID: 20215781 RESULT

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Francesco Locatelli, MD

  Nephrology and Dialysis Department - A. Manzoni Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Simeone Andrulli, MD

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 30, 2008
• Study Start: July 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: July 1, 2007
• Last Updated: September 25, 2020

Record last verified: 2020-09

Locations

IT (1)