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 |
| Secondary identifying numbers | ESA-2 |
- 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
Scientific
Department of Kidney and Tranpslant Medicine
West Wing, Basement
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
Study information
| Study design | Randomised controlled open trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 |
| 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 |
| 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 | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Department of Kidney and Tranpslant Medicine
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Sponsor information
Barts and the London NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Office
3rd Floor Rutland House
42-46 New Road
Whitechapel
London
E1 2AX
England
United Kingdom
| Website | http://www.bartsandthelondon.org.uk/ |
|---|---|
"ROR" |
https://ror.org/00b31g692 |
Funders
Funder type
Industry
Roche Pharmaceuticals (UK) - salary of research doctor through the hospital Research and Develpment Department (ref: ML20597)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
