Condition category
Haematological Disorders
Date applied
16/08/2006
Date assigned
03/10/2006
Last edited
09/05/2016
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

Prof Magdi Yaqoob

ORCID ID

Contact details

Department of Kidney Medicine and Transplantation
Basement West Wing
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ESA - 1

Study information

Scientific title

A randomised, open label controlled trial of Epoetin Beta in the treatment of Anaemia Post-Transplantation

Acronym

Epoetin Beta in PTA

Study hypothesis

The treatment of post-transplant anaemia with epoetin beta decreases the rate of decline of kidney function and the quantity of proteinuria. It also affects markers of cardiovascular disease, endothelial dysfunction and tubular damage, and blood pressure control.

Ethics approval

Submitting in August 2006 to East London and the City Health Authority Ethics Committee.

Study design

Randomised controlled open 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

Post-transplant anaemia

Intervention

Treatment with epoetin beta.

Intervention type

Drug

Phase

Not Specified

Drug names

Epoetin Beta

Primary outcome measures

1. Rate of decline of glomerular filtration rate (GFR)
2. Change in blood pressure control
3. Change in quantity of proteinuria

Secondary outcome measures

1. Change in left ventricular hypertrophy (LVH) as measured on echocardiogram
2. Change in intimal and medial wall thickness as determined by intimal medial thickness and flow dependant vasodilation as determined by ultrasound
3. Changes in functional quality of life scores
4. Changes in markers of tubular damage in the urine
5. Changes in markers of endothelial dysfunction

Overall trial start date

01/10/2006

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female patients greater than three months post-kidney transplant
2. Haemoglobin less than 11.5 g/dl and greater than 9.0 g/dl
3. Age greater than 18 years of age and less than 85 years of age

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Current treatment with an erythropoiesis stimulating agent (ESA)
2. Uncontrolled hypertension
3. Congestive cardiac failure (New York Heart Association [NYHA] grade III and IV)
4. History of seizures
5. History of thombotic episodes
6. Pregnancy
7. Lactation
8. Presence of systemic disease, infection or inflammatory conditions
9. Hepatic insufficiency
10. Active hepatitis
11. Uncontrolled hypothyroidism
12. Chronic alcoholism
13. Known hypersensitivity to the active substance in the cartridge or benzoic acid
14. Known sensitivity to Epoetin Beta

Recruitment start date

01/10/2006

Recruitment end date

30/09/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Kidney Medicine and Transplantation
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Barts and the London NHS Trust (UK)

Sponsor details

Joint Research and Developement Office
3rd Floor Rutland House
42-46 New Street
Whitechapel
London
E1 2AX
United Kingdom
+44 (0)20 7882 7250
Gerry.Leonard@bartsandthelondon.nhs.uk

Sponsor type

Government

Website

http://www.bartsandthelondon.nhs.uk/research

Funders

Funder type

Industry

Funder name

Roche Products Ltd (UK) - provided an educational grant though the Joint Research Department for the salary of the Research Fellow

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

09/05/2016: No publications found, verifying study status with principal investigator.