The purpose of this study is to ask whether treating non-diabetic chronic kidney disease (CKD) patients with GFR 8-20mL/min/1.73m2 by darbepoetin Alfa targeting Hb between 11.0 and 13.0g/dL preserves renal function better than targeting Hb between 9.0 and11.0g/dL. The investigators also ask whether the higher Hb targeting 11 to 13g/dL will not cause higher adverse events regarding cardiovascular diseases compared with lower Hb targeting 9 to 11g/dL.
Anemia is common among patients with chronic kidney disease (CKD) and is associated with an increased risk of cardiovascular and renal events. Although erythropoiesis stimulating agent (ESA) has been used to correct anemia, use of ESA (hemoglobin level at approximately 13 g/dL) did not reduce cardiovascular or renal events in diabetic CKD patients. Subgroup analysis of a recent randomized study suggested that use of darbepoetin alfa targeting Hb between 11 and 13 g/dL may preserve renal function better than targeting Hb between 9 and 11g/dL in non-diabetic CKD patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
476
Darbepoetin alfa is used for targeting Hb level of 11-13g/dL in high Hb group, and 9-11g/dL in low Hb group.
Showa University School of Medicine
Shinagawa, Tokyo, Japan
Composite renal outcome of chronic dialysis, kidney transplantation, eGFR 6 mL/min/1.73m2 or less, or eGFR less than 50% of initial value.
Time frame: 96 weeks
Composite cardiovascular outcome of cardiovascular death, stroke, myocardial infarction, leg amputation, admission by heart failure or angina.
Time frame: 96 weeks
Time from enrollment to initiation of dialysis
Time frame: 96 weeks
Time from enrollment to 50% reduction of eGFR from initial value
Time frame: 96 weeks
Time from enrollment to death by any cause
Time frame: 96 weeks
Change of eGFR from enrollment
Time frame: 96 weeks
Change of proteinuria/Cr ratio
Time frame: 96 weeks
Renal protection in patients who maintained the target Hb more than half the time
Time frame: 96 weeks
50% renal survival
Time frame: 96 weeks
Stroke
Time frame: 96 weeks
Myocardial infarction
Time frame: 96 weeks
Development of malignancy
Time frame: 96 weeks
Number of Participants with Adverse Events baseline
Time frame: 96 weeks
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