A randomised, open label controlled trial of Epoetin Beta in the treatment of anaemia post-transplantation

ISRCTN	ISRCTN41687085
DOI	https://doi.org/10.1186/ISRCTN41687085
EudraCT/CTIS number	2006-003502-26
Secondary identifying numbers	ESA - 1

Submission date: 16/08/2006
Registration date: 03/10/2006
Last edited: 06/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Haematological Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Magdi Yaqoob
Scientific

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

Study information

Study design	Randomised controlled open trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	A randomised, open label controlled trial of Epoetin Beta in the treatment of Anaemia Post-Transplantation
Study acronym	Epoetin Beta in PTA
Study objectives	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(s)	Submitting in August 2006 to East London and the City Health Authority Ethics Committee.
Health condition(s) or problem(s) studied	Post-transplant anaemia
Intervention	Treatment with epoetin beta.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/10/2006
Completion date	30/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	120
Total final enrolment	55
Key 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
Key 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
Date of first enrolment	01/10/2006
Date of final enrolment	30/09/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Kidney Medicine and Transplantation

London
E1 1BB
United Kingdom

Sponsor information

Barts and the London NHS Trust (UK)
Hospital/treatment centre

Joint Research and Developement Office
3rd Floor Rutland House
42-46 New Street
Whitechapel
London
E1 2AX
England
United Kingdom

Phone	+44 (0)20 7882 7250
Email	Gerry.Leonard@bartsandthelondon.nhs.uk
Website	http://www.bartsandthelondon.nhs.uk/research
"ROR"	https://ror.org/00b31g692

Funders

Funder type

Industry

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2020	06/01/2021	Yes	No

Editorial Notes

06/01/2021: Publication reference, total final enrolment and EudraCT number added.
09/05/2016: No publications found, verifying study status with principal investigator.