A Study to Evaluate Whether Correction of Anemia Using Recombinant Human Erythropoietin Reduces the Progression of Atherosclerosis and Cardiac Hypertrophy in Pre-dialysis Chronic Kidney Disease Patients

Not Applicable

Completed

• Conditions: Chronic Disease; Kidney Diseases; Cardiovascular Diseases

• Registration Number: NCT00563355
• Lead Sponsor: Hospital Authority, Hong Kong

Brief Summary

The primary aim of the study is to evaluate the effects of correction of anemia using erythropoietin on the progression of atherosclerosis and cardiac muscle thickening in patients with chronic kidney disease

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Study Completion: 2003-11
• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-23
• Study First Posted: 2007-11-26
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-14
• Last Update Posted: 2011-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Patients with chronic renal failure with serum creatinine between 150umol/L and 800umol/L and at the same time Hb
• Patients with regression line of 1/serum creatinine versus time showing that they may not require dialysis within the coming 12 months
• Patients below the age of 75

Exclusion Criteria

• Patients with valvular heart disease/congenital heart disease
• Patients with ischemic heart disease/history of myocardial infarction/coronary artery bypass surgery
• Patients with history of heart failure
• Patients with regression line of 1/serum creatinine versus time showing that the estimated date of end stage renal disease is within 12 months
• Patients with thalassemic trait or haemoglobinopathies
• Patients with underlying haematological malignancies
• Patients with active bleeding
• Patients with uncorrected iron or other vitamins deficiencies
• Patients with poor general condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
endothelial function and atherosclerosis	6 month, 1 year
cardiac hypertrophy and cardiac function	6 month, 1 year

Secondary Outcome Measures

Name	Time	Method
nutrition status	6 month, 1 year
residual renal function	6 month, 1 year
quality of life	6 month, 1 year

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇨🇳 Hong Kong, China