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

Completed

Conditions: Anaemia in diabetic nephropathy
Haematological Disorders
Anaemia

Registration Number: ISRCTN66395033

Lead Sponsor: Barts and the London NHS Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 160

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Rate of decline of renal function as determined by estimated glomerular filtration rate (GFR)<br>2. Composite end-point of:<br>2.1. Doubling of creatinine<br>2.2. Reaching end-stage renal failure<br>2.3. Death

Secondary Outcome Measures

Name	Time	Method
1. Change in left ventricular hypertrophy as measured on echocardiogram<br>2. Change in intimal and medial wall thickness as determined by intimal thickness and flow dependant vasodilation as determined by ultrasound <br>3. Change in functional quality of life scores<br>4. Change in markers of endothelial dysfunction<br>5. Change of markers of tubular damage in the urine