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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list