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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.
Sponsor:
Collaborator:
The Hong Kong Society of Nephrology
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00563355
First received: November 21, 2007
Last updated: June 14, 2011
Last verified: June 2011
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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
The 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

No publications provided

ClinicalTrials.gov Identifier: NCT00563355     History of Changes
Other Study ID Numbers: CRE2000.241, HARECCTR0500004
Study First Received: November 21, 2007
Last Updated: June 14, 2011
Health Authority: Hong Kong: Ethics Committee

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

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Chronic Disease
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Cardiomegaly
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes
 Pathologic Processes
Urologic Diseases
Renal Insufficiency
Heart Diseases
Hypertrophy
Pathological Conditions, Anatomical
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013