Diabetes MellitusNCT00907608
A Proof-of-Concept Study of Darbepoetin Alfa in Partial Correction of Anemia in Chinese With Diabetic Nephropathy
A study testing Darbepoetin alfa in people with Diabetes Mellitus and Chronic Kidney Disease, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The purpose of this study is to examine the effect of partial correction of anemia with Darbepoetin alfa to a target of 11 g.dL (female) or 12 g/dL (male) on the reduction of cardiovascular morbidity and total mortality. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes Mellitus, Chronic Kidney Disease, Anemia
- What is being tested?
- Darbepoetin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- Dec 2007to May 2009
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged above 20 years old
- Patients with Type 1 or Type 2 diabetes mellitus
- Estimated glomerular filtration rate less than 59 mL/min/1.73m2
- Patients not on renal replacement therapy
- Hemoglobin level at baseline : women less than 9.5 g/dL (inclusive) and men less than 10.5 g/dL (inclusive)
- All patients should be on a stable dose of the following medications 4 weeks before enrolment :
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- Aspirin 80mg daily unless contraindicated
- Statin to achieve stable and optimal LDL-cholesterol level
- Maximal tolerated dose of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers
- Anti-hypertensive treatment to maintain blood pressure target of less than 130/80 mmHg or a level achieved without undue side effects
- Oral anti-diabetic drugs or insulin to maintain HbA1C less than 9.5%
Who cannot join
- Pregnancy, breast feeding or patient has plans of becoming pregnant during the study period
- Known non-diabetic renal disease
- Known cause of anemia not related to chronic kidney disease
- Presence of hemoglobinopathy
- History of pure red cell aplasia
- Known allergy to Darbepoetin alfa
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- Severe liver impairment (>= 3x ULN of ALT)
- Poorly controlled hypertension, systolic BP >= 160mmHg or diastolic BP >= 100mmHg
- Significant cardiovascular disease within 3 months of enrolment including acute coronary syndrome, cardiac revascularization procedure, transient ischemic attack and cerebrovascular accident
- History of major gastrointestinal bleeding in the 5 years prior to consent
- Investigational drugs within 30 days of enrolment
- Any other medical conditions that is considered as unsuitable for the study by investigator
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the effect of partial correction of anemia with Darbepoetin alfa to a target of 11 g.dL (female) or 12 g/dL (male) on the reduction of cardiovascular morbidity and total mortality.
Read the detailed description
Diabetes is the leading cause of end stage renal disease and cardiovascular disease with 60 percent of the global diabetic population coming from Asia. Growing evidence confirms the predictive role of chronic kidney disease (CKD) on cardiovascular morbidity and mortality. This is due to the constellation of conventional and non-conventional risk factors in patients who develop CKD, such as anemia, inflammation and abnormal bone metabolism. In this regard, anemia is a risk factor for cardiovascular disease and all-cause mortality in patients with CKD, patients with left ventricular dysfunction and in general population.
Effective erythropoiesis is dependent on the production of erythropoietin by the kidneys. Anemia is a common finding in patients with diabetes and up to 20% of diabetic patients are noted to have anemia. In a meta-analysis of community-based population studies, anemia interacts with CKD to increase the risk of coronary heart disease, stroke and all-cause mortality among patients with diabetes. Previous studies that examined the effect of erythropoietin therapy on anemic subjects with CKD did not find statistical difference in mortality rates between the treated and untreated groups. Possible explanations for the lack of benefits include higher level of blood pressure and increased blood viscosity leading to worsening of chronic congestive heart failure in the treated subjects. We hypothesize that partial correction of hemoglobin may be more appropriate.
- Conditions
- Diabetes Mellitus, Chronic Kidney Disease, Anemia
- Being tested
- Darbepoetin alfa
- Medical subject headings
- Diabetes Mellitus, Renal Insufficiency, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin alfaDrug
Starting dose of 20 microgram per week, to be titrated over a 3-month period until target hemoglobin level is reached (female: 11 g/dL and male: 12 g/dL). Route of administration is subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Receive Darbepoetin alfa Receives: Drug: Darbepoetin alfa |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite cardiovascular endpoint of myocardial infarction, congestive heart failure, arrhythmia, stroke, transient ischemic attack, amputation or ulceration / necrosis of lower limb
Measured: 3 years
Death
Measured: 3 years
Secondary outcomes (6)
Doubling of mean serum creatinine
Measured: 3 years
50% reduction in mean estimated glomerular filtration rate during baseline period as estimated by the abbreviated Modification of Diet in Renal Disease equation
Measured: 3 years
Estimated glomerular filtration rate less than 15 mL/min/1.73m-2
Measured: 3 years
Change in fasting urinary albumin creatinine ratio
Measured: 3 years
Need for dialysis
Measured: 3 years
Number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startDec 2007
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: Due to difficulty in patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Peter CY Tong, MBChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907608
- Sponsor's protocol ID
- PWH-2008-darbe
- Status last verified
- May 2009
- First submitted
- 21 May 2009
- Last updated
- 22 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept Study of Darbepoetin Alfa in Partial Correction of Anemia in Chinese With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT00907608
- Acronym / sponsor ID
- PWH-2008-darbe
- Conditions
- Diabetes Mellitus, Chronic Kidney Disease, Anemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to difficulty in patient recruitment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 22 May 2009 (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 purpose of this study is to examine the effect of partial correction of anemia with Darbepoetin alfa to a target of 11 g.dL (female) or 12 g/dL (male) on the reduction of cardiovascular morbidity and total mortality.
Detailed description
Diabetes is the leading cause of end stage renal disease and cardiovascular disease with 60 percent of the global diabetic population coming from Asia. Growing evidence confirms the predictive role of chronic kidney disease (CKD) on cardiovascular morbidity and mortality. This is due to the constellation of conventional and non-conventional risk factors in patients who develop CKD, such as anemia, inflammation and abnormal bone metabolism. In this regard, anemia is a risk factor for cardiovascular disease and all-cause mortality in patients with CKD, patients with left ventricular dysfunction and in general population.
Effective erythropoiesis is dependent on the production of erythropoietin by the kidneys. Anemia is a common finding in patients with diabetes and up to 20% of diabetic patients are noted to have anemia. In a meta-analysis of community-based population studies, anemia interacts with CKD to increase the risk of coronary heart disease, stroke and all-cause mortality among patients with diabetes. Previous studies that examined the effect of erythropoietin therapy on anemic subjects with CKD did not find statistical difference in mortality rates between the treated and untreated groups. Possible explanations for the lack of benefits include higher level of blood pressure and increased blood viscosity leading to worsening of chronic congestive heart failure in the treated subjects. We hypothesize that partial correction of hemoglobin may be more appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Darbepoetin alfaReceive Darbepoetin alfa |
| 2 | No intervention | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients aged above 20 years old
- Patients with Type 1 or Type 2 diabetes mellitus
- Estimated glomerular filtration rate less than 59 mL/min/1.73m2
- Patients not on renal replacement therapy
- Hemoglobin level at baseline : women less than 9.5 g/dL (inclusive) and men less than 10.5 g/dL (inclusive)
Key exclusion criteria (12 listed)
- Pregnancy, breast feeding or patient has plans of becoming pregnant during the study period
- Known non-diabetic renal disease
- Known cause of anemia not related to chronic kidney disease
- Presence of hemoglobinopathy
- History of pure red cell aplasia
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 |
|---|---|---|
| Darbepoetin alfaStarting dose of 20 microgram per week, to be titrated over a 3-month period until target hemoglobin level is reached (female: 11 g/dL and male: 12 g/dL). Route of administration is subcutaneous injection. | Drug | 1 |
Primary outcome
Composite cardiovascular endpoint of myocardial infarction, congestive heart failure, arrhythmia, stroke, transient ischemic attack, amputation or ulceration / necrosis of lower limb
Time frame: 3 years
Death
Time frame: 3 years
6 secondary outcomes
Doubling of mean serum creatinine
Time frame: 3 years
50% reduction in mean estimated glomerular filtration rate during baseline period as estimated by the abbreviated Modification of Diet in Renal Disease equation
Time frame: 3 years
Estimated glomerular filtration rate less than 15 mL/min/1.73m-2
Time frame: 3 years
Change in fasting urinary albumin creatinine ratio
Time frame: 3 years
Need for dialysis
Time frame: 3 years
Number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Due to difficulty in patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2009.
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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.
Peter CY Tong, MBChB principal investigator
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 Darbepoetin alfa in people with Diabetes Mellitus and Chronic Kidney Disease, run by Chinese University of 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 11 inclusion and 12 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: stopped early, as of the sponsor's last update on 22 May 2009. 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 was stopped early (reason given: Due to difficulty in patient recruitment). Results are not available in the source record.
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?
Composite cardiovascular endpoint of myocardial infarction, congestive heart failure, arrhythmia, stroke, transient ischemic attack, amputation or ulceration / necrosis of lower limb (time frame: 3 years). 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?
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 22 May 2009.