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

This study has been completed.

First Received: November 21, 2007 Last Updated: June 23, 2009 History of Changes

Sponsors and Collaborators:	Hospital Authority, Hong Kong Hong Kong Society of Nephrology
Information provided by:	Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:	NCT00563355

Purpose

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

Condition	Intervention
Chronic Disease Kidney Diseases Cardiovascular Diseases	Drug: erythropoietin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Anemia Coping with Chronic Illness Kidney Failure

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:

endothelial function and atherosclerosis [ Time Frame: 6 month, 1 year ]
cardiac hypertrophy and cardiac function [ Time Frame: 6 month, 1 year ]

Secondary Outcome Measures:

nutrition status [ Time Frame: 6 month, 1 year ]
residual renal function [ Time Frame: 6 month, 1 year ]
quality of life [ Time Frame: 6 month, 1 year ]

Enrollment:	66
Study Start Date:	February 2001
Study Completion Date:	November 2003

Eligibility

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563355

Locations

China
Prince of Wales Hospital
Hong Kong, China

Sponsors and Collaborators

Hospital Authority, Hong Kong

Hong Kong Society of Nephrology

Investigators

Principal Investigator:

Angela YM Wang, Dr

Department of Medicine & Therapeutics/Nephrology, Prince of Wales Hospital/ The Chinese University of Hong Kong

More Information

Additional Information:

HAREC Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CRE2000.241, HARECCTR0500004
Study First Received:	November 21, 2007
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00563355 History of Changes
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:

chronic kidney disease
cardiovascular disease

Study placed in the following topic categories:

Epoetin Alfa
Atherosclerosis
Arterial Occlusive Diseases
Renal Insufficiency
Hematinics
Kidney Failure, Chronic
Anemia
Disease Progression

Vascular Diseases
Arteriosclerosis
Hypertrophy
Urologic Diseases
Renal Insufficiency, Chronic
Chronic Disease
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Epoetin Alfa
Atherosclerosis
Arterial Occlusive Diseases
Renal Insufficiency
Disease Attributes
Hematinics
Hematologic Agents
Kidney Failure, Chronic
Vascular Diseases
Arteriosclerosis

Pharmacologic Actions
Pathologic Processes
Urologic Diseases
Renal Insufficiency, Chronic
Therapeutic Uses
Cardiovascular Diseases
Chronic Disease
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on September 10, 2009