Additional identifiers
EudraCT number
2009-017505-11
ClinicalTrials.gov number
Protocol/serial number
6879
Study information
Scientific title
A study to assess the effects of a vitamin E bonded haemodialysis membrane on erythropoiesis simulating agent requirements and fibrin clot structure and function in chronic haemodialysis patients
Acronym
VITAL
Study hypothesis
Does dialysis with a vitamin E bonded haemodialysis membrane reduce erthyropoesis stimulating agent requirements over 12 months in chronic haemodialysis patients?
Ethics approval
Leeds (West) Research Ethics Committee (REC) approved on the 26th February 2009 (ref: 08/H1307/144)
Study design
Randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal
Intervention
Control: Rexeed Dialyser
Intervention: Vitabran E dialyser
Follow Up Length: 12 month(s)
Intervention type
Supplement
Phase
Not Applicable
Drug names
Vitamin E
Primary outcome measure
Haemoglobin concentration and erythropoeisis stimulating agent requirements at 6 months and 12 months
Secondary outcome measures
Data collected at 6 and 12 months on:
1. Markers of oxidative stress
2. Fibrin clot structure
Overall trial start date
01/10/2009
Overall trial end date
01/02/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Dialysis patient managed by Leeds Teaching Hospitals NHS Trust Renal Unit
2. Established on HD for at least 3 months prior to entry into study
3. Patients expected to remain on haemodialysis for at least 6 months
4. Written consent and willingness to participate in the study
5. Aged greater than 18 years at point of entry into study
6. Patients on a 3 times a week dialysis schedule
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 348
Participant exclusion criteria
1. Unwillingness or inability to cooperate or give written informed consent
2. Terminally ill patients (expected survival less than 6 months)
3. Medical conditions requiring regular blood transfusion at the time of study enrolment
4. Any serious medical, social or psychological condition that in the opinion of the investigator would disqualify from participation
5. Patients with a significant inflammatory illness within 3 months as defined by a C-reactive protein (CRP) greater than 50 mg/L or 3 x patient's baseline CRP
Recruitment start date
01/10/2009
Recruitment end date
01/02/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Renal Medicine
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
Leeds Teaching Hospitals NHS Trust (UK)
Sponsor details
Beckett Street
Leeds
LS9 7TF
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Asahi Kasei Medical Corporation (Japan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24293660