Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/08/2012
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 R Dedi

ORCID ID

Contact details

Renal and Liver Services
St James's University Hospital
Beckett Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 243 3144

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436121433

Study information

Scientific title

Acronym

Study hypothesis

Haemodialysis patients are currently treated with intravenous iron and subcutaneous recombinant human erythropoietin to treat anaemia associated with end-stage renal failure. To ensure optimum erythropoiesis, iron stores, as judged by serum ferritin, are kept above the normal range. Recently, a novel form of modified erythropoietin, darbopoetin alfa (Aranesp®), has been licensed for use. This has a longer duration of action and needs to be administered only once a week. Consequently, it does not result in a burst of erythropoietic activity. It is assumed that the prolonged erythropoiesis does not result in peaks of iron utilisation, and so requires lower levels of available iron, which can be replenished from iron stores sufficiently rapidly to continue to support erythropoiesis. We propose to study the effect of maintaining "normal" ferritin levels compared with "supranormal" ferritin in stable haemodialysis patients receiving Aranesp®.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Haemodialysis

Intervention

Randomised controlled trial. Random allocation to:
1. Maintenance of normal ferritin
2. Maintenance of elevated ferritin (standard therapy)

Intervention type

Drug

Phase

Not Specified

Drug names

Darbepoetin (Aranesp®)

Primary outcome measures

Haemoglobin (g/dl), Darbepoetin (ug/kg/week), Serum Ferritin, Iron Dose (mg/kg/week). Transferrin saturation percentage. C-reactive protein.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2002

Overall trial end date

30/11/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients will be drawn from the population of haemodialysis patients attending Leeds General Infirmary renal unit.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2002

Recruitment end date

30/11/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Renal and Liver Services
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