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| The effect of treating patients with anaemia in diabetic nephropathy to different target haemoglobin levels with epoetin beta |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN66395033 |
| Date ISRCTN assigned | 04/12/2006 |
| Local reference number(s) | ESA-2 |
| Public title | The effect of treating patients with anaemia in diabetic nephropathy to different target haemoglobin levels with epoetin beta |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Anaemia in Diabetic Nephropathy |
| 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. |
| Design/methodology | Randomised, controlled, open trial |
| Research ethics review | Applied for to the East London and the City Health Authority Reserach Ethics Committee One - expecting to go to Ethics meeting in early November 2006. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/12/2006 |
| Anticipated end date | 30/11/2009 |
| Status of trial | Ongoing |
| Target number of participants | 160 |
| Interventions | 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. |
| Primary outcome measure(s) | 1. Rate of decline of renal function as determined by estimated Glomerular Filtration Rate (GFR) 2. Composite end-point of: a. doubling of creatinine b. reaching end-stage renal failure c. death |
| 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 |
| Sources of funding | Salary of research doctor funded through the hospital Research and Develpment Department by Roche Pharmaceuticals ( ML20597) (UK) |
| Sponsor name | Barts and the London NHS Trust (UK) |
| Sponsor details | Research and Development Office 3rd Floor Rutland House 42-46 New Road Whitechapel London United Kingdom E1 2AX |
| Sponsor website | http://www.bartsandthelondon.org.uk/ |
| Contact name | Prof Magdi Yaqoob |
| Contact details | Department of Kidney and Tranpslant Medicine West Wing, Basement Royal London Hospital Whitechapel London United Kingdom E1 1BB |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN66395033 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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