Post-transplant anaemia Haematological Disorders Anaemia
Conditions
Interventions
Treatment with epoetin beta.
Sponsors
Barts and the London NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Rate of decline of glomerular filtration rate (GFR) 2. Change in blood pressure control 3. Change in quantity of proteinuria | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed