This study will define an effective starting dose for subcutaneous administration of MK2578 to correct anemia in erythropoiesis-stimulating agent (ESA)-naive patients with chronic kidney disease (CKD) who are not on dialysis while evaluating its safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Change From Baseline in Hemoglobin Level at Week 4
Time frame: 4 weeks
Number of Participants With Composite Events of Death, Myocardial Infarction and Cerebrovascular Accident, Serious Events of Unstable Angina, Transient Ischemic Attack, Arrythmia and Congestive Heart Failure, Peripheral Thrombo-embolic Events
Time frame: 16 Weeks
Number of Participants With Composite Events of Transfusion-related Adverse Experiences
Time frame: 16 Weeks
Number of of Participants With Composite Events of Injection Site Reactions
Time frame: 16 Weeks
Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia
Time frame: 16 Weeks
Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578
Time frame: 16 Weeks
Hemoglobin Concentration After Treatment With MK2578
Time frame: Weeks 1-10 and Week 12
Change From Baseline in Hemoglobin Level
Time frame: Weeks 1-3, 5-10, and Week 12
Number of Participants Who Were Responders
Responder was defined as a participant achieving (pre-transfusion) an increase from baseline hemoglobin of greater than or equal to 1 g/dL and a hemoglobin concentration of greater than or equal to 11 g/dL.
Time frame: Each week up to 12 weeks
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