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Main
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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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13 January 2015 |
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Main ID: |
ISRCTN66395033 |
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Date of registration:
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04/12/2006 |
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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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The effect of treating patients with anaemia in diabetic nephropathy to different target haemoglobin levels with epoetin beta
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Scientific title:
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Date of first enrolment:
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01/12/2006 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN66395033 |
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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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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Magdi
Yaqoob |
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Address:
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Department of Kidney and Tranpslant Medicine
West Wing, Basement
Royal London Hospital
Whitechapel
E1 1BB
London
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male and female patients with diabetic nephropathy and chronic kidney disease III and IV
2. Age more than 18 years and less than 80 years
3. Haemoglobin less than 11.5 g/dl
Exclusion criteria: 1. Current treatment with an erythropoiesis-stimulating agent (ESA)
2. Uncontrolled hypertension
3. Congestive cardiac failure
4. History of seizures
5. History of thrombotic 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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Anaemia in diabetic nephropathy
Haematological Disorders
Anaemia
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Intervention(s)
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All patients should be iron replete (i.e. ferritin 0.1 or Tsats 0.2%) before randomisation. Participants will be given intravenous (IV) iron to replete iron stores if required before randomisation.
Participants will be randomised to two target ranges of haemoglobin on a 1:1 basis. Target ranges:
1. Hb 10.5 - 12 g/dl
2. Hb 12.1 - 13.5 g/dl
Participants will be treated with Epoetin Beta subcutaneously, if required, to maintain their haemoglobin within the target group. This will be a starting dose of 50 units/kg/week given once a week. Dose will be titrated on a monthly basis to start with, and then modified according to response (total dose 720 units/kg/week). Participants will be treated for three years.
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Primary Outcome(s)
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1. Rate of decline of renal function as determined by estimated glomerular filtration rate (GFR)
2. Composite end-point of:
2.1. Doubling of creatinine
2.2. Reaching end-stage renal failure
2.3. Death
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Secondary Outcome(s)
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1. Change in left ventricular hypertrophy as measured on echocardiogram
2. Change in intimal and medial wall thickness as determined by intimal thickness and flow dependant vasodilation as determined by ultrasound
3. Change in functional quality of life scores
4. Change in markers of endothelial dysfunction
5. Change of markers of tubular damage in the urine
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Source(s) of Monetary Support
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Roche Pharmaceuticals (UK) - salary of research doctor through the hospital Research and Develpment Department (ref: ML20597)
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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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