Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
26/01/2016
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 Paul Laboi

ORCID ID

Contact details

Department of Renal Medicine
Wellcome Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436121434

Study information

Scientific title

Is functional iron deficiency the cause of anaemia in haemodialysis patients with dialysis catheters? A randomised controlled study

Acronym

Study hypothesis

To confirm the presence of functional iron deficiency in iron replete haemodialysis patients with dialysis catheters.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Haemodialysis

Intervention

Randomised controlled trial. Random allocation to:
1. Treatment one
2. Treatment two

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. To determine the relationship between functional iron deficiency and EPO resistance.
2. Serum ferritin
3. iron
4. transferrin saturation
5. percentage of hypochromic erthrocytes
6. haematocrit
7. reticulocyte count
8. reticulocyte haemoglobin concentration
9. serum C-r

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2002

Overall trial end date

01/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Haemodialysis patients over 18 years of age on dialysis treatment for at least 3 months
2. Stable haemodialysis patients dialyzing with a central venous catheter on erythropoietin (EPO) therapy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/10/2002

Recruitment end date

01/10/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

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

Publication citations

Additional files

Editorial Notes

26/01/2016: no publications found on PubMed.