Status:
TERMINATED
A Proof-of-Concept Study of Darbepoetin Alfa in Partial Correction of Anemia in Chinese With Diabetic Nephropathy
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Diabetes Mellitus
Chronic Kidney Disease
Eligibility:
All Genders
20+ years
Phase:
NA
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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 :
- 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%
Exclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00907608
Start Date
December 1 2007
End Date
May 1 2009
Last Update
May 22 2009
Active Locations (1)
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1
Prince of Wales Hospital
Hong Kong, China