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 |
| Clinical Trials Information System (CTIS) | 2006-003502-26 |
| Protocol serial number | ESA - 1 |
| Sponsor | Barts and the London NHS Trust (UK) |
| Funder | Roche Products Ltd (UK) - provided an educational grant though the Joint Research Department for the salary of the Research Fellow |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Department of Kidney Medicine and Transplantation
Basement West Wing
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled open trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Epoetin Beta |
| Primary outcome measure(s) |
1. Rate of decline of glomerular filtration rate (GFR) |
| Key secondary outcome measure(s) |
1. Change in left ventricular hypertrophy (LVH) as measured on echocardiogram |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
E1 1BB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
