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
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
2 other identifiers
interventional
66
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2001
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 21, 2007
CompletedFirst Posted
Study publicly available on registry
November 26, 2007
CompletedJune 16, 2011
June 1, 2011
November 21, 2007
June 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
endothelial function and atherosclerosis
6 month, 1 year
cardiac hypertrophy and cardiac function
6 month, 1 year
Secondary Outcomes (3)
nutrition status
6 month, 1 year
residual renal function
6 month, 1 year
quality of life
6 month, 1 year
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Authority, Hong Konglead
- The Hong Kong Society of Nephrologycollaborator
Study Sites (1)
Prince of Wales Hospital
Hong Kong, China
Related Publications (1)
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PMID: 36791280DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angela YM Wang, Dr
Department of Medicine & Therapeutics/Nephrology, Prince of Wales Hospital/ The Chinese University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
November 21, 2007
First Posted
November 26, 2007
Study Start
February 1, 2001
Study Completion
November 1, 2003
Last Updated
June 16, 2011
Record last verified: 2011-06