Condition category
Haematological Disorders
Date applied
17/11/2006
Date assigned
04/05/2007
Last edited
07/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Samir Agrawal

ORCID ID

Contact details

Barts and the London NHS Trust
St Bartholomew’s Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
+44 (0)20 7601 2331
s.g.agrawal@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00482716

Protocol/serial number

Version 2 (Oct 2006)

Study information

Scientific title

Acronym

High Iron Study

Study hypothesis

Parental iron will optimise the response to recombinant erythropoietin therapy in patients who are iron replete.

Ethics approval

Approval received from the East London and the City Research Ethics Committee on the 17th October 2006 (ref: 06/Q0605/93).

Study design

Randomised, controlled, open label, prospective trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chemotherapy induced anaemia

Intervention

As of 07/08/2009 the status of this record was updated to read: 'STOPPED', as this trial terminated early due to poor patient recruitment. The initial anticipated end date was 01/11/2007 but this was extended after the lack of recruitment.

Eighty patients will be treated and randomised to receive either epoietin or epoietin plus 200 mg intravenous iron sucrose (Venefor) weekly for ten weeks or until a haemoglobin (Hb) of 13 g/dl is achieved (whichever is first). Any patient requiring blood transfusion while on the study will be considered to have completed the study at the time of the transfusion. Patients will be followed until the Hb reaches 13 g or until the end of the study period. Haemoglobin levels will be measured weekly.

Other blood tests include:
Baseline: zinc protoporphyrin (ZPP), reticulocyte haemoglobin content (CHR), transferrin saturation (TSAT), full blood count (FBC), ferritin, reticulocytes (Retic), vitamin B12, red cell folate, soluble transferrin receptor (sTFR), serum erythropoietin (EPO)
Week one: FBC, CHR, retic
Week four, eight and 12: as per baseline (without B12 and red cell folate)

Intervention type

Supplement

Phase

Not Specified

Drug names

Iron supplementation (Venefor), epoietin

Primary outcome measures

The primary outcome will be the maximum haemoglobin achieved during the conduct of the study.

Secondary outcome measures

The secondary outcome will be the time to zenith haemoglobin or the achievement of a haemoglobin level of more than 13 g. All side effects will be recorded and graded although none are anticipated. A further stratification will be responsive, stable or progressive disease.

Overall trial start date

01/11/2006

Overall trial end date

24/04/2009

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

1. Any patients with a haemoglobin of less than or equal to 10.5 g/dl who is going to receive at least six more weeks of chemotherapy for any non-myeloid malignancy
2. Any patients with a percent saturation of transferrin more than or equal to 20% and a serum ferritin between 225 and 2250 pmol/L. Confirmatory data will include a reticulocyte haemoglobin content (CHR) more than 31 and zinc protoporphyrin (ZPP) less than 80
3. Patients must be able to understand and signed written informed consent
4. An Eastern Cooperative Oncology Group (ECOG) performance status of zero to two

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Eighty patients

Participant exclusion criteria

1. Patients with an anaemia of origin other than cancer or cancer chemotherapy
2. Prior intravenous (IV) iron therapy
3. Expectation of actual transfusion requirement during the course of the study. A transfusion given after randomisation wil be a study endpoint for that patient.
4. Allergy or intolerance to recombinant erythropoietin
5. Uncontrolled hypertension
6. Active infection
7. Primary bone marrow malignancies except for multiple myeloma, chronic lymphocytic leukaemia and indolent non Hogkin's lymphoma, where erythropoiesis-stimulating agents (ESA) therapy has been proven to be beneficial

Recruitment start date

01/11/2006

Recruitment end date

24/04/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barts and the London NHS Trust
London
EC1A 7BE
United Kingdom

Sponsor information

Organisation

Barts and the London NHS Trust (UK)

Sponsor details

Research and Development Department
3rd Floor Rutland House
42-46 New Road
Whitechapel
London
E1 2AX
United Kingdom
+44 (0)20 7882 7260
Gerry.Leonard@bartsandthelondon.nhs.uk

Sponsor type

Government

Website

http://www.bartsandthelondon.org.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

St. Bartholomew's Hospital (UK) - internal funding

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