Diabetes Mellitus Clinical Trial
Official title:
A Proof-of-Concept Study of Darbepoetin Alfa in Partial Correction of Anemia in Chinese With Diabetic Nephropathy
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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