A Proof-of-Concept Study of Darbepoetin Alfa in Partial Correction of Anemia in Chinese With Diabetic Nephropathy

• Status: Terminated
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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