Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
ESA-2
Study information
Scientific title
Acronym
Study hypothesis
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
Study design
Randomised controlled open trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Condition
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
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Epoetin beta
Primary outcome measure
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
Secondary outcome measures
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
Overall study start date
01/12/2006
Overall study end date
30/11/2009
Reason abandoned (if study stopped)
Objectives no longer viable
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
80 Years
Sex
Both
Target number of participants
160
Participant 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
Recruitment start date
01/12/2006
Recruitment end date
30/11/2009
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Department of Kidney and Tranpslant Medicine
London
E1 1BB
United Kingdom
Sponsor information
Organisation
Barts and the London NHS Trust (UK)
Sponsor details
Research and Development Office
3rd Floor Rutland House
42-46 New Road
Whitechapel
London
E1 2AX
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
http://www.bartsandthelondon.org.uk/
ROR
Funders
Funder type
Industry
Funder name
Roche Pharmaceuticals (UK) - salary of research doctor through the hospital Research and Develpment Department (ref: ML20597)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|