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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Interventions

  • Drug: erythropoietin

Clinical Trial Outcome Measures

Primary Measures

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

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 75 Years

Investigator Details

  • Lead Sponsor
    • Hospital Authority, Hong Kong
  • Collaborator
    • The Hong Kong Society of Nephrology
  • Overall Official(s)
    • Angela YM Wang, Dr, Principal Investigator, Department of Medicine & Therapeutics/Nephrology, Prince of Wales Hospital/ The Chinese University of Hong Kong

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