Condition category
Urological and Genital Diseases
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
20/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simon Lines

ORCID ID

Contact details

Department of Renal Medicine
Beckett Street
Leeds
LS9 7TF
United Kingdom

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 measures

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

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

http://www.leedsteachinghospitals.com/

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24293660

Publication citations

Additional files

Editorial Notes

20/07/2016: Publication reference added