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

Not Applicable

Completed

• Conditions: Post-transplant anaemia; Haematological Disorders; Anaemia

• Registration Number: ISRCTN41687085
• Lead Sponsor: Barts and the London NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-03
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Rate of decline of glomerular filtration rate (GFR)<br>2. Change in blood pressure control<br>3. Change in quantity of proteinuria

Secondary Outcome Measures

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