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

Phase 2

Terminated

• Conditions: Anemia; Chronic Kidney Disease
• Interventions: Drug: MK2578

• Registration Number: NCT00968617
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-27
• Study First Submitted QC: 2009-08-28
• Study First Posted: 2009-08-31
• Study Start: 2009-11
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Results First Submitted: 2011-10-07
• Results First Submitted QC: 2011-10-07
• Results First Posted: 2011-11-11
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-30
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK2578 3.6 mcg/kg	MK2578	MK2578
MK2578 1.0 mcg/kg	MK2578	MK2578
MK2578 2.0 mcg/kg	MK2578	MK2578

Primary Outcome Measures

Name	Time	Method
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
Change From Baseline in Hemoglobin Level at Week 4	4 weeks

Secondary Outcome Measures

Name	Time	Method
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	Each week up to 12 weeks	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.