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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00563355
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : June 16, 2011
The Hong Kong Society of Nephrology
Information provided by:
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

Condition or disease Intervention/treatment Phase
Chronic Disease Kidney Diseases Cardiovascular Diseases Drug: erythropoietin Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2001
Actual Study Completion Date : November 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. endothelial function and atherosclerosis [ Time Frame: 6 month, 1 year ]
  2. cardiac hypertrophy and cardiac function [ Time Frame: 6 month, 1 year ]

Secondary Outcome Measures :
  1. nutrition status [ Time Frame: 6 month, 1 year ]
  2. residual renal function [ Time Frame: 6 month, 1 year ]
  3. quality of life [ Time Frame: 6 month, 1 year ]

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00563355

Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
The Hong Kong Society of Nephrology
Principal Investigator: Angela YM Wang, Dr Department of Medicine & Therapeutics/Nephrology, Prince of Wales Hospital/ The Chinese University of Hong Kong Identifier: NCT00563355     History of Changes
Other Study ID Numbers: CRE2000.241
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: June 2011

Keywords provided by Hospital Authority, Hong Kong:
chronic kidney disease
cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Chronic Disease
Urologic Diseases
Renal Insufficiency
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes
Pathologic Processes
Epoetin Alfa