A Study of MK2578 in Patients With Chronic Kidney Disease Who Are Not on Dialysis (2578-002)

Study Overview
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Brief Summary
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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.

Official Title
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A Phase IIb Randomized, Active Comparator-Controlled, Open-Label Clinical Trial to Study the Efficacy and Safety of MK2578 for the Treatment of Anemia in ESA (Erythropoiesis-Stimulating Agent)-Naive Patients With Chronic Kidney Disease Who Are Not on Dialysis.

Conditions
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Anemia, Chronic Kidney Disease

Intervention / Treatment
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* Drug: MK2578
* Drug: MK2578
* Drug: MK2578
* Drug: Comparator: darbepoetin alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is male or is a female who either cannot have children or who agrees to use appropriate contraceptive measures Patient has chronic kidney disease Exclusion Criteria: Patient is morbidly obese Patient has used another erythropoiesis (red blood cell formation) stimulating agent within 12 weeks of screening Patient will require dialysis during the study or is planning to have a kidney transplant within the next 6 months Patient has had a blood transfusion within 12 weeks of screening Patient has had major surgery within the past 12 weeks or plans to have surgery Patient has Human Immunodeficiency Virus (HIV) Patient has a history of diseases other than CKD known to cause anemia Patient has severe congestive heart failure Patient has history of malignant cancer, except certain skin or cervical cancers Patient has a history of grand mal seizures within the last 6 months Patient is pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK2578 1.0 mcg/kg<br>MK2578 | Drug: MK2578<br>* MK2578 1.0 mcg/kg/month<br>|
| Experimental: MK2578 2.0 mcg/kg<br>MK2578 | Drug: MK2578<br>* MK2578 2.0 mcg/kg/month<br>|
| Experimental: MK2578 3.6 mcg/kg<br>MK2578 | Drug: MK2578<br>* MK2578 3.6 mcg/kg/month<br>|
| Active Comparator: Darbepoetin alfa<br>darbepoetin alfa | Drug: Comparator: darbepoetin alfa<br>* darbepoetin alfa<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin Level at Week 4 |  | 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 |  | 16 Weeks | 
| Number of Participants With Composite Events of Transfusion-related Adverse Experiences |  | 16 Weeks | 
| Number of of Participants With Composite Events of Injection Site Reactions |  | 16 Weeks | 
| Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia |  | 16 Weeks | 
| Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578 |  | 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Concentration After Treatment With MK2578 |  | Weeks 1-10 and Week 12 | 
| Change From Baseline in Hemoglobin Level |  | 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. | Each week up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia