Back to resultsA 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
Primary Purpose
Chronic Disease, Kidney Diseases, Cardiovascular Diseases
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
erythropoietin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Disease focused on measuring chronic kidney disease, cardiovascular disease
Eligibility 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
Sites / Locations
- Prince of Wales Hospital
Outcomes
Primary Outcome Measures
endothelial function and atherosclerosis
cardiac hypertrophy and cardiac function
Secondary Outcome Measures
nutrition status
residual renal function
quality of life
Full Information
NCT ID
NCT00563355
First Posted
November 21, 2007
Last Updated
June 14, 2011
Sponsor
Hospital Authority, Hong Kong
Collaborators
The Hong Kong Society of Nephrology
1. Study Identification
Unique Protocol Identification Number
NCT00563355
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
The Hong Kong Society of Nephrology
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Kidney Diseases, Cardiovascular Diseases
Keywords
chronic kidney disease, cardiovascular disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
erythropoietin
Primary Outcome Measure Information:
Title
endothelial function and atherosclerosis
Time Frame
6 month, 1 year
Title
cardiac hypertrophy and cardiac function
Time Frame
6 month, 1 year
Secondary Outcome Measure Information:
Title
nutrition status
Time Frame
6 month, 1 year
Title
residual renal function
Time Frame
6 month, 1 year
Title
quality of life
Time Frame
6 month, 1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
75 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela YM Wang, Dr
Organizational Affiliation
Department of Medicine & Therapeutics/Nephrology, Prince of Wales Hospital/ The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
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
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