Chronic DiseaseNCT00563355
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 study testing erythropoietin in people with Chronic Disease and Kidney Diseases, run by Hospital Authority, Hong Kong at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Chronic Disease, Kidney Diseases, Cardiovascular Diseases
- What is being tested?
- erythropoietin
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- Feb 2001to Nov 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients with active bleeding
- Patients with uncorrected iron or other vitamins deficiencies
- Patients with poor general condition
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Chronic Disease, Kidney Diseases, Cardiovascular Diseases
- Being tested
- erythropoietin
- Keywords
- chronic kidney disease, cardiovascular disease
- Medical subject headings
- Chronic Disease, Kidney Diseases, Cardiovascular Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erythropoietinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial function and atherosclerosis
Measured: 6 month, 1 year
cardiac hypertrophy and cardiac function
Measured: 6 month, 1 year
Secondary outcomes (3)
nutrition status
Measured: 6 month, 1 year
residual renal function
Measured: 6 month, 1 year
quality of life
Measured: 6 month, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startFeb 2001
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- The Hong Kong Society of Nephrology
- Investigators
- Angela YM Wang, Dr, Principal investigator, Department of Medicine & Therapeutics/Nephrology, Prince of Wales Hospital/ The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563355
- Sponsor's protocol ID
- CRE2000.241
- Other IDs
- HARECCTR0500004
- Status last verified
- Jun 2011
- First submitted
- 21 Nov 2007
- Last updated
- 16 Jun 2011
- Results posted
- No
Publications
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.
PubMed 36791280
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00563355
- Acronym / sponsor ID
- CRE2000.241
- Conditions
- Chronic Disease, Kidney Diseases, Cardiovascular Diseases
- Keywords
- chronic kidney disease, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- The Hong Kong Society of Nephrology
- Study start
- Feb 2001
- Study completion
- Nov 2003 (actual)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erythropoietin | Drug | – |
Primary outcome
endothelial function and atherosclerosis
Time frame: 6 month, 1 year
cardiac hypertrophy and cardiac function
Time frame: 6 month, 1 year
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
- Derived from this study: PubMed 36791280Chung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela YM Wang, Dr principal investigator
Department of Medicine & Therapeutics/Nephrology, Prince of Wales Hospital/ The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erythropoietin in people with Chronic Disease and Kidney Diseases, run by Hospital Authority, Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endothelial function and atherosclerosis (time frame: 6 month, 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00563355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2011.