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NCT00563355 Clinical Trial

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

Cardiovascular Diseases Clinical Trial

Official title:
A Prospective Randomised Controlled Trial to Study the Effects of Recombinant Human Erythropoietin on the Progression of Atherosclerosis, Cardiovascular Function, Nutrition and Residual Renal Function in Pre-dialysis Chronic Renal Failure Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00563355
Other study ID # CRE2000.241
Secondary ID HARECCTR0500004
Status Completed
Phase N/A
First received November 21, 2007
Last updated June 14, 2011
Start date February 2001
Est. completion date November 2003

Study information
Verified date June 2011
Source Hospital Authority, Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date November 2003
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• erythropoietin

Locations
Country Name City State
China Prince of Wales Hospital Hong Kong

Sponsors (2)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong The Hong Kong Society of Nephrology

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary endothelial function and atherosclerosis 6 month, 1 year
Primary cardiac hypertrophy and cardiac function 6 month, 1 year
Secondary nutrition status 6 month, 1 year
Secondary residual renal function 6 month, 1 year
Secondary quality of life 6 month, 1 year
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