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NCT Number: NCT00563355

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 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

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Key information

Conditions

Chronic Disease Cardiovascular Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythropoietin

Drug

Primary outcomes

  1. endothelial function and atherosclerosis

    Time frame: 6 month, 1 year

  2. cardiac hypertrophy and cardiac function

    Time frame: 6 month, 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Authority, Hong Kong

Other Gov

Collaborators

  • The Hong Kong Society of Nephrology

Registry information

Official study 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

Important dates

Study start
2001
Study completion
2003
First posted
Nov 26, 2007
Registry last updated
Jun 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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