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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN41687085 |
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Date of registration:
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03/10/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A randomised, open label controlled trial of Epoetin Beta in the treatment of anaemia post-transplantation
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Scientific title:
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A randomised, open label controlled trial of Epoetin Beta in the treatment of Anaemia Post-Transplantation |
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Date of first enrolment:
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01/10/2006 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN41687085 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled open trial (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Magdi
Yaqoob |
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Address:
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Department of Kidney Medicine and Transplantation
Basement West Wing
Royal London Hospital
Whitechapel
E1 1BB
London
United Kingdom |
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Post-transplant anaemia
Haematological Disorders
Anaemia
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Intervention(s)
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Treatment with epoetin beta.
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Primary Outcome(s)
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1. Rate of decline of glomerular filtration rate (GFR)
2. Change in blood pressure control
3. Change in quantity of proteinuria
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Roche Products Ltd (UK) - provided an educational grant though the Joint Research Department for the salary of the Research Fellow
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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