Condition category
Haematological Disorders
Date applied
17/10/2006
Date assigned
04/12/2006
Last edited
09/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Magdi Yaqoob

ORCID ID

Contact details

Department of Kidney and Tranpslant Medicine
West Wing
Basement
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom

Additional identifiers

EudraCT 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

Not provided at time of registration

Study design

Randomised controlled open trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial 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

Phase

Not Applicable

Drug names

Epoetin beta

Primary outcome measures

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 trial start date

01/12/2006

Overall trial end date

30/11/2009

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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
United Kingdom

Sponsor type

Government

Website

http://www.bartsandthelondon.org.uk/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes