The effect of treating patients with anaemia in diabetic nephropathy to different target haemoglobin levels with epoetin beta

ISRCTN	ISRCTN66395033
DOI	https://doi.org/10.1186/ISRCTN66395033
Protocol serial number	ESA-2
Sponsor	Barts and the London NHS Trust (UK)
Funder	Roche Pharmaceuticals (UK) - salary of research doctor through the hospital Research and Develpment Department (ref: ML20597)

Submission date: 17/10/2006
Registration date: 04/12/2006
Last edited: 09/02/2009

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Haematological Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Magdi Yaqoob
Scientific

Department of Kidney and Tranpslant Medicine
West Wing, Basement
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
Scientific title
Study objectives	That treating patients with anaemia in diabetic nephropathy to a higher haemoglobin target range decreases rate of decline of renal function, requirement for dialysis, doubling of creatinine and death.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Anaemia in diabetic nephropathy
Intervention	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.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Epoetin beta
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/11/2009
Reason abandoned (if study stopped)	Objectives no longer viable

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	160
Key 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
Key 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
Date of first enrolment	01/12/2006
Date of final enrolment	30/11/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Kidney and Tranpslant Medicine

London
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